3Q2015 3Q2015EXCEL DMF# 29815
STATUS TYP SUBMIT DATE HOLDER E A IV 9/28/2015 SUN PHARMACEUTICAL INDUSTRIES LTD
SUBJECT ZONISAMIDE AUSP S
29847
A
IV
9/23/2015
VSP TECHNOLOGIES INC
ZYTREL(TM)
29820
A
IV
9/15/2015
SANOFI CHIMIE
ZOPICLONE
29768
A
IV
9/10/2015
GLENMARK PHARMACEUTICALS LTD
ZOLPIDEM TARTRATE USP
29754
A
IV
9/4/2015
CADILA PHARMACEUTICALS LTD
ZOLPIDEM TARTRATE
29515
A
IV
8/12/2015
CUNO INC
ZETA PLUS CA MEDIA AND CARTRIDGES
29599
A
IV
7/29/2015
RUETGERS NEASE CHEMICAL CO INC
ZINC PYRION - NS
29627
A
IV
7/29/2015
AMINO CHEMICALS LTD
ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE
29666
A
IV
7/29/2015
IPCA LABORATORIES LTD
ZOLEDRONIC ACID
29573
A
IV
7/22/2015
HEC PHARM CO LTD
ZIDOVUDINE, NON-STERILE DRUG SUBSTANCE, BULK FORM
29570
A
IV
7/17/2015
MYLAN LABORATORIES LTD
ZIDOVUDINE USP (PROCESS II)
29572
A
IV
7/17/2015
RANBAXY LABORATORIES LTD
ZIDOVUDINE USP DRUG SUBSTANCE
29559
A
IV
7/10/2015
HETERO LABS LTD
ZIDOVUDINE (PROCESS I)
29545
A
IV
7/8/2015
CUNO INC
ZETAPOR 0.20UM ST MEMBRANE CARTRIDGES, MERIDEN, CT
29530
A
IV
7/2/2015
3M PURIFICATION INC
29541
A
IV
6/26/2015
CUNO EUROPE SA
ZETA PLUS™ AP, CA, CP HP, HTP, HTM, L, LA, LP, LPM, M, SA, SP, VR, Z, ZA AND DELIPID PRODUCT SERIES ZETA-PLUS DELIPID DEL 1 AND DEL 1 LP SERIES
29543
A
IV
6/26/2015
CUNO EUROPE SA
ZETA-PLUS LP AND LPM SERIES
29544
A
IV
6/26/2015
CUNO INC
ZETAPOR 0.20 UM AND 0.45 SP FLAT STOCK MEMBRANE
29612
A
IV
6/25/2015
REYNOLDS PRESTO PRODUCTS INC
ZIPPER STYLE CLOSURES
29333
A
IV
6/22/2015
WHATMAN
WHATMAN DE52 (DIETHYLAMINOETHYL CELLULOSE)
29495
A
IV
6/22/2015
BIO VECTRA INC
ZERANOL
29499
A
IV
6/22/2015
CUNO INC
ZETA PLUS 05 SP MEDIA CARTRIDGES AND FLAT STOCK
29542
A
IV
6/22/2015
CUNO EUROPE SA
ZETA-PLUS HTP AND HTM SERIES
29438
A
IV
6/3/2015
YMC CO LTD
YMC
29423
A
IV
5/28/2015
XYLOCAINE
29474
A
IV
5/28/2015
JENSEN-SALSBERY LABS DIV RICHARDSONMERRILL INC AMINO CHEMICALS LTD
ZALEPLON
29478
A
IV
5/28/2015
GADOR SA
ZALEPLON
29479
A
IV
5/28/2015
ORCHID CHEMICALS AND PHARMACEUTICALS LTD ZALEPLON
29202
A
IV
5/27/2015
VERNAY LABORATORIES INC
VL201N25 & VL201X22 COMPOUNDS
29387
A
IV
5/26/2015
CLARIANT CORP
WLC-12486, 25/1 WHITE COLOR CONCENTRATE
29551
A
IV
5/25/2015
CUNO INC
ZETAPREP QEA MEDIA
29394
A
IV
5/15/2015
ASH STEVENS INC
WR 242511
29381
A
IV
5/14/2015
KUNSHAN WISEPAC DESICCANT CO LTD
WISECAN DESICCANT CANISTER
29366
A
IV
5/11/2015
KUKDONG OIL AND CHEMICAL CO LTD
WHITE MINERAL OIL LILY-50
29379
A
IV
5/11/2015
TAISEI KAKO CO LTD
WIDE ORIFICE BOTTLES AND CLOSURES FOR TABLETS
29617
A
IV
5/9/2015
LUPIN LTD
ZIPRASIDONE HYDROCHLORIDE
29358
A
IV
5/5/2015
CCC PLASTICS
WHITE MB50-926 POLYPROPYLENE COLOUR CONCENTRATE
29344
A
IV
5/4/2015
BEATSON CLARK PLC
WHITE FLINT GLASS CONTAINERS
Page 1
3Q2015 3Q2015EXCEL DMF# 29319
STATUS TYP SUBMIT DATE HOLDER E A IV 4/28/2015 WEST PHARMACEUTICAL SERVICES INC
SUBJECT
29324
A
IV
4/20/2015
WEST PHARMACEUTICAL SERVICES INC
WESTAR(R) RS PROCESS
29337
A
IV
4/17/2015
RESCO COLOURS INC
WHITE CONCENTRATE (01EHD-260)
29296
A
IV
4/15/2015
AKZO NOBLE INKS CORP
WATER-BASED PRINTING INK PRODUCTS ; UV-CURABLE PRINTING INK PRODUCTS
29280
A
IV
4/10/2015
RAKS PHARMA PVT LTD
WARFARIN SODIUM CLATHRATE USP
29310
A
IV
4/10/2015
WEDTECH INC
WEDTECH 1005 WHITE FOR USE IN PACKAGING MATERIALS
29311
A
IV
4/10/2015
INGENIA POLYMERS CORP
WEDTECH WT-157 WHITE FOR USE IN PACKAGING MATERIALS
29312
A
IV
4/10/2015
WEST AMERICAN RUBBER CO
WEST AMERICAN RUBBER COMPOUND 55-P-146
29279
A
IV
4/9/2015
IPCA LABORATORIES LTD
WARFARIN SODIUM CLATHRATE USP
29218
A
IV
3/30/2015
DR REDDYS LABORATORIES LTD
VORICONAZOLE, USP (PROCESS-II)
29234
A
IV
3/30/2015
DOW CHEMICAL CO
WALOCEL(R) HM HYPROMELLOSE USP
29072
A
IV
3/28/2015
LPS INDUSTRIES INC
VF60(METALIZED POLYESTER/LLDPE LAMINATION)
29457
A
IV
3/26/2015
PACIFIC NORTHWEST NATIONAL LABORATORY
YTTRIUM-90 (Y-90)
29203
A
IV
3/25/2015
VETTER PHARMA FERTIGUNG GMBH AND CO KG
V-LK(R) S-CARTRIDGE SYSTEM
29223
A
IV
3/11/2015
ELI LILLY AND CO
VORTEL TABLETS
29171
A
IV
3/9/2015
SHOWA DENKO KK
VISCOMATE NP-700 (PARTIALLY NEUTRALIZED POLYACRYLATE)
29172
A
IV
3/9/2015
TREDEGAR MOLDED PRODS
VISQUEEN 0-102 (MD-30) C-1 TREATED POLYETHYLENE SHEETING
29173
A
IV
3/9/2015
EXXONMOBIL CHEMICAL CO
VISTANEX LM POLYISOBUTYLENE PRODUCTS
29174
A
IV
3/9/2015
EXXONMOBIL CHEMICAL CO
VISTANEX POLYISOBUTYLENE RUBBER
29152
A
IV
3/2/2015
CIPLA LTD
VINORELBINE TARTRATE USP
29108
A
IV
2/27/2015
MSN PHARMACHEM PRIVATE LTD
VILDAGLIPTIN [ROUTE CODE - "VG"]
29110
A
IV
2/27/2015
MINAKEM HIGH POTENT
VINBLASTIN SULFATE
29111
A
IV
2/27/2015
MEDIMPEX NORTHAMERICA INC
VINBLASTINE SO4 FOR INJECT, USP 10 MG
29089
A
IV
2/13/2015
ICI LTD
VICTREX (TM) POLYETHERSULFONO RESIN
29077
A
IV
2/6/2015
SHINIL PHARM GLASS CO LTD
VIALS
29049
A
IV
2/2/2015
FERMION OY
VERAPAMIL HCL BP 80 ADD. 82
29013
A
IV
1/22/2015
TEVA PHARMACEUTICAL INDUSTRIES LTD
VENLAFAXINE HYDROCHLORIDE
29022
A
IV
1/15/2015
NOVUS FINE CHEMICALS LLC
VENLAFAXINE HYDROCHLORIDE
29000
A
IV
1/8/2015
SIEGFRIED USA LLC
VENLAFAXINE HYDROCHLORIDE
28972
A
IV
12/29/2014
PENINSULA LABS INC
VASOACTIVE INTESTINAL PEPTIDE
28980
A
IV
12/26/2014
HEINKE TECHNOLOGY INC
VCA5 VAGINAL CREAM APPLICATOR
28968
A
IV
12/24/2014
JOGUE CORP
VARIOUS FLAVOR FORMULATIONS
28662
A
IV
12/17/2014
GIST BROCADES
TYROTHRICIN
29186
A
IV
12/17/2014
BASF AKTIENGESELLSCHAFT
VITAMIN C (1,000MG.)TABLET & VITAMIN C PLACEBO TABLETS
29187
A
IV
12/17/2014
29188
A
IV
12/17/2014
SICHUAN NEIJIANG HUIXIN PHARMACEUTICAL CO VITAMIN D2 LTD SUPREEM PHARMACEUTICALS MYSORE PVT LTD VITAMIN D3 (CHOLECALCIFEROL) WATER SOLUBLE 100 IU/MG
28921
A
IV
12/15/2014
AUROBINDO PHARMA LTD
VALSARTAN USP (PROCESS II)
28981
A
IV
12/10/2014
HEINKE TECHNOLOGY INC
VCA-6CC VAGINAL CREAM APPLICATOR
28937
A
IV
12/5/2014
ABBVIE INC
VANCOMYCIN HYDROCHLORIDE
28892
A
IV
12/3/2014
ANJAN DRUG PRIVATE LTD
VALPROIC ACID USP
WESTAR LINED SEAL RS WASHING PROCESS
Page 2
3Q2015 3Q2015EXCEL DMF# 28883
STATUS TYP SUBMIT DATE HOLDER SUBJECT E A IV 11/26/2014 NIPPON SYNTHETIC CHEMICAL INDUSTRY CO LTD VALPROIC ACID
28884
A
IV
11/26/2014
LIANYUNGANG PHARMACEUTICAL FACTORY
VALPROIC ACID
27766
A
IV
11/21/2014
P L BIOCHEMICALS
THYMUS GLAND "FRACTION 3"
28846
A
IV
11/20/2014
APOTEX PHARMACHEM INDIA PVT LTD
VALACYCLOVIR HYDROCHLORIDE MONOHYDRATE USP
28847
A
IV
11/20/2014
MYLAN LABORATORIES LTD
VALACYCLOVIR HYDROCHLORIDE USP
28848
A
IV
11/20/2014
DIVIS LABORATORIES LTD
VALACYCLOVIR HYDROCHLORIDE USP (HYDROUS FORM)
28849
A
IV
11/20/2014
SUN PHARMACEUTICAL INDUSTRIES LTD
VALACYCLOVIR HYDROCHLORIDE USP (HYDROUS)
28850
A
IV
11/20/2014
MYLAN LABORATORIES LTD
VALACYCLOVIR HYDROCHLORIDE USP (VCR)
28851
A
IV
11/20/2014
HUBEI YITAI PHARMACEUTICAL CO LTD
VALACYCLOVIR HYDROCHLORIDE(NON-STERILE, BULK FORM)
28852
A
IV
11/20/2014
VALACYCLOVIR HYDROCHLORIDE, ANHYDROUS FORM II
28853
A
IV
11/20/2014
ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTD TAIZHOU HIGHSUN PHARMACEUTICAL CO LTD
VALACYCLOVIR HYDROCHLORIDE, NON-STERILE DRUG SUBSTANCE
28854
A
IV
11/20/2014
CALYX CHEMICALS AND PHARMACEUTICALS LTD
VALGANCICLOVIR HYDROCHLORIDE
28855
A
IV
11/20/2014
DR REDDYS LABORATORIES LTD
VALGANCICLOVIR HYDROCHLORIDE (AMORPHOUS)
28856
A
IV
11/20/2014
SUN PHARMACEUTICAL INDUSTRIES LTD
VALGANCICLOVIR HYDROCHLORIDE (NON-STERILE BULK)
28857
A
IV
11/20/2014
APOTEX PHARMACHEM INC
VALGANCICLOVIR HYDROCHLORIDE USP
28858
A
IV
11/20/2014
CIPLA LTD
VALGANCICLOVIR HYDROCHLORIDE USP
28859
A
IV
11/20/2014
MYLAN LABORATORIES LTD
VALGANCICLOVIR HYDROCHLORIDE USP (AMORPHOUS)
28871
A
IV
11/17/2014
LABORATORY ANALYTICAL BIOLOGY INC
VALIDATION REPORT ON NITROGLYCERIN METABOLITES
28872
A
IV
11/17/2014
LABORATORY ANALYTICAL BIOLOGY INC
VALIDATION REPORT ON PRAZEPAM AND IT'S MAJOR METABOLITES
28839
A
IV
11/12/2014
PIRAMAL ENTERPRISES LTD
VALACYCLOVIR HYDROCHLORIDE
28829
A
IV
11/7/2014
MACLEODS PHARMACEUTICALS LTD
VALACICLOVIR HYDROCHLORIDE DIHYDRATE
28830
A
IV
11/7/2014
HETERO DRUGS LTD
VALACICLOVIR HYDROCHLORIDE MONOHYDRATE
28836
A
IV
11/7/2014
WOCKHARDT LTD
Valacyclovir Hydrochloride
28809
A
IV
11/4/2014
3V PARTECIPAZIONI INDUSTRIALI SPA
UVASORB MET/C
28234
A
IV
11/3/2014
BAYER PHARMA AG
TRASYLOL (APROTININ)-DRUG SUBSTANCE
28728
A
IV
10/31/2014
INGREDION INC
UNIPURE(TM) DW
28794
A
IV
10/31/2014
TOMITA PHARMACEUTICAL CO LTD
USP MAGNESIUM OXIDE HEAVY FINE GRANULAR
28795
A
IV
10/27/2014
TOMITA PHARMACEUTICAL CO LTD
USP MAGNESIUM OXIDE HEAVY POWDER
28650
A
IV
10/23/2014
TYLOSIN TARTRATE
28751
A
IV
10/20/2014
ZHEJIANG APELOA KANGYU BIO PHARMACEUTICAL CO LTD PFANSTIEHL LABORATORIES INC
UREA PEROXIDE, U-102
28705
A
IV
10/3/2014
BASF SE
ULTRAFORM S2320 003 PRO UNCOLORED
28706
A
IV
10/3/2014
BASF SE
ULTRAFORM W 2320 003
28707
A
IV
10/3/2014
BASF SE
ULTRAFORM W 2320 003 UNCOLORED Q600
28708
A
IV
10/3/2014
BASF SE
ULTRAFORM W2320 003 PRO TR UNCOLORED
28709
A
IV
10/3/2014
BASF SE
ULTRAFORM W2320 003 PRO UNCOLORED
28710
A
IV
10/3/2014
BASF AKTIENGESELLSCHAFT
ULTRAFORM W2320 007
28711
A
IV
10/3/2014
BASF SE
ULTRAFORM® H4320 PRO UNCOLORED
Page 3
3Q2015 3Q2015EXCEL DMF#
SUBJECT
28712
STATUS TYP SUBMIT DATE HOLDER E A IV 10/3/2014 BASF SE
28713
A
IV
10/3/2014
SCHERING CHEMICALS LTD
ULTRALANUM CREAM PLAIN
28714
A
IV
10/3/2014
BASF AKTIENGESELLSCHAFT
ULTRAPEK A 1000
28715
A
IV
10/3/2014
BASF AKTIENGESELLSCHAFT
ULTRAPEK A 2000
28716
A
IV
10/3/2014
BASF AKTIENGESELLSCHAFT
ULTRAPEK A 3000
28717
A
IV
10/3/2014
BASF AKTIENGESELLSCHAFT
ULTRAPEK KR 4175, 4176, 4177 AND 4178
28718
A
IV
10/3/2014
REPLIGEN CORP
ULTRAPURE RECOMBINANT PROTEIN A
28719
A
IV
10/3/2014
MCCLURE ROBERT E MR
ULTRASONIC DEVICE
28720
A
IV
10/3/2014
ULTRAVIOLET ABSORBERS (U.V.Q, U.V. 24, & U.V.24 PHARMACEUTICAL GRADE)
28619
A
IV
9/29/2014
LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO THERMAX LTD CHEMICAL DIV
TULSION(R) 344
28683
A
IV
9/29/2014
UNION CARBIDE CORP
UCAR SOLUTION VINYL RESINS
28684
A
IV
9/29/2014
UNION CARBIDE CORP
UCC MASTER MILKER SYSTEM FOR TC-99 EXTRACTION FROM MO-99
28685
A
IV
9/29/2014
KYOWA HAKKO KIRIN CO LTD
UCN-01 (KW-2401) BULK SUBSTANCE
28686
A
IV
9/29/2014
UNION CARBIDE CORP
UCON PROPELLANTS
28687
A
IV
9/29/2014
UNION CARBIDE CORP
UDEL POLYSULFONE RESIN P-1700
28688
A
IV
9/29/2014
DR REDDYS LABORATORIES LTD
UDENAFIL
28690
A
IV
9/29/2014
TEVA PHARMACEUTICAL INDUSTRIES LTD
ULIPRISTAL ACETATE
28691
A
IV
9/29/2014
FORMOSA LABORATORIES INC
ULIPRISTAL ACETATE
28692
A
IV
9/29/2014
CRYSTAL PHARMA SAU
ULIPRISTAL ACETATE MICRONIZED
28693
A
IV
9/29/2014
GEDEON RICHTER PLC
ULIPRISTAL ACETATE MICRONIZED
28694
A
IV
9/29/2014
POLYONE CORP
ULTIMATE 390
28695
A
IV
9/29/2014
APTAR STELMI SAS
ULTRACLEAN-6 WASHING PROCESS,
28696
A
IV
9/29/2014
BASF SE
ULTRADUR B 4500 NATURAL
28778
A
IV
9/24/2014
FALK GMBH AND CO
URSODEOXYCHOLIC ACID (URSOFALK CAPS)
28652
A
IV
9/17/2014
AMRI RENSSELAER INC
TYLOXAPOL, USP EXCIPIENT
28643
A
IV
9/10/2014
ST GOBAIN PERFORMANCE PLASTICS CORP
TYGON(R) LFL BIOPHARMACEUTICAL TUBING
28644
A
IV
9/10/2014
ST GOBAIN PERFORMANCE PLASTICS FRANCE
TYGON(R) S-50-HL MEDICAL/SURGICAL TUBING
28738
A
IV
9/10/2014
DOW CHEMICAL CO
UNS-TETRAFLUOROETHANE
28624
A
IV
9/8/2014
FINE ORGANICS LTD
TVA
28607
A
IV
8/31/2014
JOBAN GLASS CO LTD
TUBULAR VIALS FOR PHARMACEUTICAL USE
28593
A
IV
8/28/2014
28592
A
IV
8/20/2014
28600
A
IV
8/20/2014
NINGBO ZHENGLI PHARMACEUTICAL PACKING CO TUBING BOROSILICATE GLASS CONTAINERS FOR PARENTERAL PREPARATIONS LTD SCHOTT XINKANG PHARMACEUTICAL PACKAGING TUBING BOROSILICATE GLASS (TYPE I, USP) CONTAINERS FOR PARENTERAL PREPARATIONS CO LTD REMY AND GEISER GMBH TUBULAR GLASS BOTTLES
28579
A
IV
8/18/2014
CODING PRODUCTS
TTR-74808
28575
A
IV
8/15/2014
CODING PRODUCTS
TTR-5903 AND TTR-7903 THERMAL TRANSFER INK RIBBONS
28576
A
IV
8/15/2014
CODING PRODUCTS
TTR-5907, TTR-5908, TTR-7907 AND TTR-7908 THERMAL TRANSFER IN RIBBONS
28577
A
IV
8/15/2014
CODING PRODUCTS
TTR-5940 THERMAL TRANSFER INK RIBBON
28578
A
IV
8/15/2014
CODING PRODUCTS
TTR-71523
ULTRAFORM® N2320 003 PRO UNCOLORED
Page 4
3Q2015 3Q2015EXCEL DMF# 28559
STATUS TYP SUBMIT DATE HOLDER E A IV 8/14/2014 ENZYMEKING BIOTECHNOLOGY CO LTD
SUBJECT TRYPSIN
28560
A
IV
8/14/2014
TRYPSIN & a - CHYMOTRYPSIN - PREPARTION & ASSAY METHODS
28835
A
IV
8/10/2014
WAITAKI INTERNATIONAL BIOSCIENCES SUB WAITAKI CANADA LTD DR REDDYS LABORATORIES LTD
28555
A
IV
8/8/2014
XIAN HUIFENG BIOCHEMISTRY GROUP CO LTD
TROXERUTIN, NON-STERILE BULK FORM
28549
A
IV
8/6/2014
MSN LABORATORIES PRIVATE LTD
TROSPIUM CHLORIDE [ROUTE CODE - "TC"]
28553
A
IV
8/4/2014
HUNAN YUANTONG PHARMACEUTICAL CO LTD
TROXERUTIN
28557
A
IV
8/4/2014
SAFC PHARMA
TRYPAN BLUE PURIFIED
28539
A
IV
8/1/2014
BASF PHARMA EVIONNAZ SA
TROSPIUM CHLORIDE
28529
A
IV
7/31/2014
CARBOGEN AMCIS AG
TROPICAMIDE
28542
A
IV
7/31/2014
GLENMARK PHARMACEUTICALS LTD
TROSPIUM CHLORIDE
28545
A
IV
7/31/2014
PROVENTUS LIFE SCIENCES PVT LTD
TROSPIUM CHLORIDE
28528
A
IV
7/30/2014
AMCIS AG
TROPICAMIDE
28509
A
IV
7/28/2014
TEKNI PLEX INC
TRI-SEAL CLOSURE LINER MATERIALS
28510
A
IV
7/25/2014
HESEGO INDUSTRY
TRISTAR NF AND TRISTAR 149
28536
A
IV
7/25/2014
HELSINN ADVANCED SYNTHESIS SA
TROSPIUM CHLORIDE
28492
A
IV
7/21/2014
JUNGBUNZLAUER LADENBURG GMBH
TRIPOTASSIUM CITRATE
28478
A
IV
7/15/2014
LUNDBECK PHARMACEUTICALS ITALY SPA
TRIMIPRAMINE MALEATE
28461
A
IV
7/1/2014
PKU HEALTHCARE CORP LTD
TRIMETHOPRIM USP
28324
A
IV
6/25/2014
BLASCHIM SPA
TRIAMCINOLONE DIACETATE
28261
A
IV
6/19/2014
INTAS PHARMACEUTICALS LTD
TRAZODONE HYDROCHLORIDE USP
28399
A
IV
6/18/2014
PROSINTEX SPA
TRIFLUOPERAZINE HCL
28402
A
IV
6/18/2014
HEINRICH MACK NACHF
TRIFLUOROTHYMIDINE
28408
A
IV
6/16/2014
ER SQUIBB AND SONS INC
TRIFLUPROMAZINE AND TRIFLUPROMAZINE HCL
28426
A
IV
6/16/2014
PCAS
TRIMEPRAZINE TARTRATE USP
28449
A
IV
6/16/2014
ALPHA DRUG INDIA LIMITED
TRIMETHOPRIM
28450
A
IV
6/16/2014
SHOUGUANG FUKANG PHARMACEUTICAL CO LTD TRIMETHOPRIM
28407
A
IV
6/12/2014
SWORDS LABORATORIES LTD
28370
A
IV
6/9/2014
28367
A
IV
6/2/2014
BRISTOL MYERS PRODUCTS DIV BRISTOL MYERS TRI-BUFFERED BUFFERIN CO INDIA PHOSPHATE TRIBASIC CALCIUM PHOSPHATE NF
28347
A
IV
5/30/2014
MOEHS IBERICA SL
TRIAMTERENE
28366
A
IV
5/30/2014
INNOPHOS INC
TRIBASIC CALCIUM PHOSPHATE GRANDULAR (TRI-TAB)
28328
A
IV
5/27/2014
FARMABIOS SPA
TRIAMCINOLONE DIACETATE
28498
A
IV
5/23/2014
ANTIBIOTICOS SPA
TRIPROLIDINE HCL. BULK FORM
28265
A
IV
5/6/2014
DIOSYNTH BV
TRENBOLONE ACETATE
28266
A
IV
5/6/2014
TREOFAN GERMANY GMBH AND CO KG
TREOFAN GND
28274
A
IV
5/6/2014
CHONGQING HUAPONT PHARMACEUTICAL CO LTD TRETINOIN
28259
A
IV
5/2/2014
MYLAN LABORATORIES LTD
VALACYCLOVIR HYDROCHLORIDE
TRIFLUPROMAZINE & TRIFLUPROMAZINE HCL
TRAZODONE HYDROCHLORIDE USP
Page 5
3Q2015 3Q2015EXCEL DMF# 28233
STATUS TYP SUBMIT DATE HOLDER E A IV 4/25/2014 BAYER PHARMA AG
SUBJECT
28239
A
IV
4/21/2014
DELTA BIOTECH SA
TRAVOPROST
28241
A
IV
4/21/2014
SCINOPHARM TAIWAN LTD
TRAVOPROST
28229
A
IV
4/18/2014
TRIFARMA SPA
TRANYLCYPROMINE SULFATE
28236
A
IV
4/18/2014
CAYMAN PHARMA SRO
TRAVOPROST
28237
A
IV
4/18/2014
CHIROGATE INTERNATIONAL INC
TRAVOPROST
28238
A
IV
4/18/2014
EVERLIGHT CHEMICAL INDUSTRIAL CORP
TRAVOPROST
28240
A
IV
4/18/2014
TRAVOPROST
28243
A
IV
4/18/2014
CHINOIN PHARMACEUTICAL AND CHEMICAL WORKS PRIVATE CO LTD JOHNSON MATTHEY PHARMA SERVICES
28227
A
IV
4/17/2014
28203
A
IV
4/14/2014
SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP DEXTER CORP
28189
A
IV
4/8/2014
ORCHID CHEMICALS AND PHARMACEUTICALS LTD TRANS RESVERATROL
28188
A
IV
4/7/2014
28185
A
IV
4/2/2014
DISHMAN PHARMACEUTICALS AND CHEMICALS LTD HUNAN DONGTING PHARMACEUTICAL CO LTD
TRANEXAMIC ACID
28198
A
IV
3/27/2014
LABELTAPE MEDITECT INC
TRANSDERMAL DRUG DELIVERY SYSTEM
28150
A
IV
3/26/2014
PROTO CHEMICALS AG
TRAMADOL HYDROCHLORIDE
28155
A
IV
3/24/2014
TONIRA PHARMA LTD
TRAMADOL HYDROCHLORIDE
28131
A
IV
3/20/2014
WADDINGTON JAYCARE LTD
TRaCeR PACK
28138
A
IV
3/20/2014
GRUNENTHAL GMBH
TRAMADOL HYDROCHLORIDE
28130
A
IV
3/18/2014
JANSSEN PHARMACEUTICA NV
TRABECTEDIN (R279741)
27877
A
IV
3/13/2014
PERRIGO API LTD
TIOTROPIUM BROMIDE MONOHYDRATE
28136
A
IV
3/13/2014
SEQUEL PHARMACHEM PRIVATE LTD
TRAMADOL HYDROCHLORID EP
28103
A
IV
3/12/2014
MALMSTROM CHEMICALS
TOXICITY STUDIES ON LANOLIN ALCOHOLS AND LANOLIN ALCOHOL DERIVATIONS
28068
A
IV
3/5/2014
SCINOPHARM TAIWAN LTD
TOPOTECAN HYDROCHLORIDE DRUG SUBSTANCE
28074
A
IV
3/5/2014
ROCHE DIAGNOSTICS GMBH
TORASEMIDE
28080
A
IV
3/5/2014
TEVA PHARMACEUTICAL INDUSTRIES LTD
TORSEMIDE
28082
A
IV
3/4/2014
HETERO LABS LTD
TORSEMIDE
28083
A
IV
3/4/2014
ZHEJIANG DONGDONG PHARMACEUTICAL CO LTD TORSEMIDE
28081
A
IV
2/26/2014
TEVA PHARMACEUTICAL INDUSTRIES LTD
TORSEMIDE
28032
A
IV
2/18/2014
BOEHRINGER MANNHEIM SA
TOPICYCLINE
27968
A
IV
1/30/2014
ORGANICHEM CORP
TOLMETIN SODIUM DIHYDRATE
27796
A
IV
1/28/2014
RAKS PHARMA PVT LTD
TICAGRELOR
27948
A
IV
1/21/2014
DIPHARMA FRANCIS SRL
TOLBUTAMIDE USP
27949
A
IV
1/20/2014
ALBERT DAVID LTD
TOLBUTAMIDE USP
27987
A
IV
1/18/2014
ITF CHEMICAL LTDA
TOLTERODINE L-TARTRATE
27942
A
IV
1/15/2014
LABOCHIM
TOLBUTAMIDE
27941
A
IV
1/14/2014
FINE CHEMICALS CORP
TOLAZOLINE HYDROCHLORIDE
TRASYLOL (APROTININ) DRUG PRODUCT
TRAVOPROST (3031.H) TRANYLCYPROMINE SULFATE TRANSDERMAL MEDICATION FABRIC
TRANS CHLOROATOVAQUONE
Page 6
3Q2015 3Q2015EXCEL DMF# 27934
STATUS TYP SUBMIT DATE HOLDER E A IV 1/13/2014 MSN LABORATORIES PRIVATE LTD
SUBJECT TOFACITINIB CITRATE [ROUTE CODE - TT"]
27914
A
IV
1/10/2014
PHARMACHIM ECONOMIC CORP
TOBRAMYCIN
27906
A
IV
1/7/2014
FINORGA SAS
TMC 125
27943
A
IV
1/6/2014
TOLBUTAMIDE
27864
A
IV
1/2/2014
STAROGAREZKIE ZAKLADY FARMACEUTYCZNE POLFA CIBA SPECIALTY CHEMICALS
TINUVIN 326
27854
A
IV
12/18/2013
UNITED STATES DEPT ENERGY
TIN-113/INDIUM-113m (DMF FORMERLY HELD BY UNION CARBIDE CORP)
27548
A
IV
12/17/2013
ANTIBIOTICOS
TETRACYCLINE PHOSPHATE COMPLEX
27828
A
IV
12/16/2013
WUHAN ZY PHARMACEUTICAL CO LTD
TIGECYCLINE
27878
A
IV
12/16/2013
DONEGAL HEALTHCARE LTD
TIP & CAP DROPPER SYSTEM
27944
A
IV
12/16/2013
PHARMACEUTICAL WORKS POLPHARMA SA
TOLBUTAMIDE
27790
A
IV
12/3/2013
TEVA PHARMACEUTICAL INDUSTRIES LTD
TICAGRELOR
27561
A
IV
11/26/2013
WEX PHARMACEUTICALS INC
TETRODOTOXIN DRUG SUBSTANCE
27757
A
IV
11/20/2013
NATIONAL INSTITUTES HEALTH CLINICAL CENTER THYMIDINE (NSC21548) PHARMACY DEPT PHARMACEUTICAL DEVELOPMENT SECTION
27758
A
IV
11/20/2013
CILAG CHEMIE AG
27716
A
IV
11/13/2013
ORION CORP LTD
THIORIDAZINE HYDROCHLORIDE
27738
A
IV
11/12/2013
KEYSTONE CAP CO
THREADED METAL CLOSURES
27688
A
IV
10/28/2013
ZAMBON SPA
THIAMPHENICOL
27689
A
IV
10/28/2013
ZAMBON SPA
THIAMPHENICOL GLYCINATE HCL
27690
A
IV
10/28/2013
THIAMYLAL SODIUM
27691
A
IV
10/28/2013
SANDOZ PHARMACEUTICALS CORP DIV SANDOZ INC EXPANSIA
27748
A
IV
10/25/2013
ANTIBIOTICOS SPA
THYMIC HUMORAL FACTOR GAMMA 2 FINISHED DOSAGE, MILAN ITALY
27653
A
IV
10/16/2013
FERRO CORP
THERMOPLASTIC COMPOUNDS (NEVOONSO1NA)
27711
A
IV
10/8/2013
FOREST LABORATORIES INC
THIORIDAZINE HCl C.R. TABLETS (IN SYNCHRON VEHICLE)
27619
A
IV
9/26/2013
ROHM PHARMA GMBH
THEOPHYLLINE R 85 D/02
27588
A
IV
9/25/2013
GE HEALTHCARE INC
THALLOUS CL (TL-201) (CYCLOTRON OPERATION)
27526
A
IV
9/18/2013
LEDERLE LABORATORIES
TETRACYCLINE HYDROCHLORIDE
27536
A
IV
9/12/2013
HOECHST MARION RSSL
TETRACYCLINE HYDROCHLORIDE
27522
A
IV
9/9/2013
TETRACYCLINE HYDROCHLORIDE
27417
A
IV
8/14/2013
COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SA OMNICHEM SA
27409
A
IV
8/9/2013
BASF AKTIENGESELLSCHAFT
TERLUX 2802 TR
27415
A
IV
8/2/2013
STYROLUTION EUROPE GMBH
TERLUX R HD 2822
27740
A
IV
8/2/2013
SCI PHARMTECH INC
THREO-PHENYL-2-PIPERIDIN-2-YL-ACETIC ACID (RITALINIC ACID)
27343
A
IV
7/25/2013
TERBINAFINE HYDROCHLORIDE (NON STERILE, API)
27329
A
IV
7/22/2013
QILU ANTIBIOTICS LINYI PHARMACEUTICAL CO LTD AMINO CHEMICALS LTD
TERBINAFINE HYDROCHLORIDE
27330
A
IV
7/22/2013
PERRIGO API LTD
TERBINAFINE HYDROCHLORIDE
THYMOPENTIN ACETATE HYDRATE
THIANAPHTEN CARBOXYLIC ACID
TERMINAL STERILIZATION PROGRAM IN GRAND ISLAND, NEW YORK.
Page 7
3Q2015 3Q2015EXCEL DMF#
27294
STATUS TYP SUBMIT DATE HOLDER E A IV 7/8/2013 BIOINDUSTRIA LABORATORIO ITALIANO MEDICINALI SPA A IV 7/5/2013 SUN PHARMACEUTICAL INDUSTRIES LTD
27267
A
IV
6/28/2013
EASTMAN CHEMICAL CO
TENITE ACETATE 036E-00969-H2
27262
A
IV
6/21/2013
SUN PHARMACEUTICAL INDUSTRIES LTD
TEMSIROLIMUS
27226
A
IV
6/18/2013
SUN PHARMACEUTICAL INDUSTRIES LTD
TELMISARTAN USP (NON-STERILE BULK)
27203
A
IV
6/5/2013
GLOCHEM INDUSTRIES LTD
TELMISARTAN
27249
A
IV
6/4/2013
RELIANCE LIFE SCIENCES PVT LTD
TEMOZOLOMIDE USP
27404
A
IV
5/24/2013
FERRING LABORATORIES INC
TERLIPRESSIN DRUG SUBSTANCE
27184
A
IV
5/15/2013
DOW CHEMICAL CO
TEFLURANE
27191
A
IV
5/15/2013
GLENMARK PHARMACEUTICALS LTD
TELAPREVIR
27199
A
IV
5/15/2013
AMINO CHEMICALS LTD
TELMISARTAN
27134
A
IV
5/1/2013
NAVINTA LLC
TAUROLIDINE
27112
A
IV
4/29/2013
TAKEDA PHARMACEUTICAL CO LTD
TAP-144-SR (3M) (22.5MG.)
27357
A
IV
4/23/2013
MELODY HEALTHCARE PVT LTD
TERBUTALINE SULPHATE
27358
A
IV
4/23/2013
ALBEMARLE CORP
TERCONAZOLE
27074
A
IV
4/11/2013
REXAM PHARMA PACKAGING INDIA PVT LTD
TAMP SAFE (O) PLASTIC CONTAINER CLOSURE SYSTEM
27072
A
IV
4/6/2013
REXAM PHARMA PACKAGING INDIA PVT LTD
TAMP LOCK / DOUBLE SAFE (R) PLASTIC CONTAINER CLOSURE SYSTEM
27055
A
IV
4/1/2013
TOKO PHARMACEUTICAL INDUSTRIES CO LTD
TAMIBAROTENE
27020
A
IV
3/28/2013
BORREGAARD AS BORREGAARD SYNTHESIS
TAI I BULK INTERMEDIATE
27014
A
IV
3/26/2013
ASAHI GLASS CO LTD
TAFLUPROST DRUG SUBSTANCE
27016
A
IV
3/12/2013
MITSUI CHEMICALS INC
TAFMER A-0585X
26941
A
IV
2/28/2013
UNIV WISCONSIN
SYNTHETIC VITAMIN D ANALOG
26899
A
IV
2/18/2013
BERRY PLASTICS
SVP PLASTIC BOTTLES
26897
A
IV
2/13/2013
JUBILANT HOLLISTERSTIER LLC
SVP FACILITY
26903
A
IV
2/13/2013
FOREST LABORATORIES INC
SYNCHRON ORAL-CARRIER
26905
A
IV
2/13/2013
SYNTHETIC PRODUCTS CO
SYNPRON 1005 VINYL HEAT STABILIZER
26908
A
IV
2/13/2013
3V INC
SYNTHALEN KP, SYNTHALEN LP, SYNTHALEN MP
26898
A
IV
2/12/2013
ARNAR STONE LABORATORIES INC
SVP FACILITY AT ARNAR-STONE LABS,INC-MOUNT PROSPECT, ILL
26854
A
IV
2/4/2013
LUITPOLD PHARMACEUTICALS INC
26859
A
IV
1/23/2013
ORGANICHEM CORP
SUPPORTING FACILITY, EQUIPMENT & VALIDATION INFORMATION MANUFACTURING FACILITY IN SHIRLEY, NY SUPROFEN
26868
A
IV
1/22/2013
HOWMEDICA INC
SURGICAL SIMPLEX P AND SURGICAL SIMPLEX RADIOPAQUE
26869
A
IV
1/22/2013
SEAL BAG CO INC
SURGI-PEEL POUCHES
26839
A
IV
1/17/2013
CRODA EUROPE LTD
SUPER REFINED SESAME OIL
26840
A
IV
1/17/2013
CRODA INC
SUPER REFINED SOYBEAN OIL
26842
A
IV
1/17/2013
GRAIN PROCESSING CORP
SUPERABSORBENT ADDITIVES USED IN DRUG DOSAGE FORMS
26809
A
IV
1/16/2013
HOVIONE FARMACIENCIA SA
SUMATRIPTAN USP
26798
A
IV
1/8/2013
MOEHS IBERICA SL
SUMATRIPTAN SUCCINATE
26780
A
IV
1/2/2013
VIRCHOW LABORATORIES LTD
SULPHAMETHOXAZOLE-USP
26884
A
IV
12/19/2012
CODING PRODUCTS
SV-16391 HOT STAMP INK RIBBONS
27305
SUBJECT TERAZOSIN HCL. 2H2O TENOFOVIR DISOPROXIL FUMARATE DRUG SUBSTANCE
Page 8
3Q2015 3Q2015EXCEL DMF# 26744
STATUS TYP SUBMIT DATE HOLDER E A IV 12/18/2012 ACF CHEMIEFARMA NV
SUBJECT
26729
A
IV
12/12/2012
TEVA GROUP
SULFAMETHOXAZOLE USP
26733
A
IV
12/12/2012
MOEHS SA DIV SANOF
SULFAMETHOXAZOLE USP XX
26697
A
IV
12/11/2012
CIECH POLFA
SULFAGUANIDINE
26698
A
IV
12/11/2012
CIECH POLFA
SULFAMERAZINE
26702
A
IV
12/11/2012
GYMA LABORATORIES AMERICA INC
SULFAMETHAZINE
26703
A
IV
12/11/2012
CIECH POLFA
SULFAMETHAZINE
26710
A
IV
12/11/2012
TOKUYAMA CORP
SULFAMETHIZOLE
26737
A
IV
12/10/2012
CHEMAPOL LTD
SULFANILAMIDE
26775
A
IV
12/3/2012
DIPHARMA SPA
SULINDAC, MANFACTURED IN MERETO DI TOMBA (UD), ITALY
26663
A
IV
11/30/2012
ZHUHAI UNITED LABORATORIES CO LTD
SULBACTAM SODIUM USP, NON-STERILE
26674
A
IV
11/29/2012
SULFADIAZINE
26634
A
IV
11/16/2012
SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTD MB SUGARS AND PHARMACEUTICALS LTD
26625
A
IV
11/12/2012
MITSUBISHI CHEMICAL CORP
26612
A
IV
11/8/2012
UNICHEM LABORATORIES LTD
26713
A
IV
11/8/2012
ACIC LTD
SULFAMETHOXAZOLE
26583
A
IV
10/26/2012
STYROLUTION AMERICA LLC
STYRENE METHYL METHACRYLATE COPOLYMER RESIN NAS30
26584
A
IV
10/26/2012
BASF AKTIENGESELLSCHAFT
STYROFAN N 920
26553
A
IV
10/16/2012
RHONE POULENC
STREPTOMYCIN SULFATE
26556
A
IV
10/16/2012
ELANCO PRODS DIV ELI LILLY AND CO
STREPTOMYCIN-TYLOSIN-ERYTHROMYCIN-PENICILLIN COMBIN. ALONE & W/DES(VET
26527
A
IV
10/4/2012
MASTERTASTE SPA
STERILIZATION VALIDATION INFORMATION
26506
A
IV
10/1/2012
MASTERTASTE SPA
STERILITY TESTING OF LARGE VOLUME PARENTERAL SOLUTION
26653
A
IV
9/28/2012
QILU TIANHE PHARMACEUTICAL CO LTD
SULBACTAM SODIUM (NON-STERILE API)
26428
A
IV
9/18/2012
DELUCA HECTOR F PHD
STERILE PROCESSING FACILITY
26433
A
IV
9/12/2012
DELUCA HECTOR F PHD
STERILE PROCESSING FACILITY FOR CEPHALOSPORIN IN JERUSALEM, ISRAEL
26384
A
IV
9/5/2012
AAIPHARMA SERVICES CORP
STERILE MANUFACTURING FACILITY IN CHARLESTON, SC
25562
A
IV
9/4/2012
BIOCON LTD
SIMVASTATIN
26371
A
IV
8/31/2012
STERIGENICS US LLC
26394
A
IV
8/29/2012
PAR STERILE PRODUCTS LLC
STERILE FINISHED PRODUCTS AND STERILE PROCESSING OPERATIONS LOCATED IN SALEM, NEW JERSEY STERILE MANUFACTURING FACILITY LOCATED IN ROCHESTER, MI
26407
A
IV
8/29/2012
SANDOZ GMBH
STERILE OXACILLIN SODIUM, BUFFERED
26197
A
IV
8/16/2012
DSM POLYMERS
STAMYLAN HD 8621
26315
A
IV
8/10/2012
QILU ANTIBIOTICS PHARMACEUTICAL CO LTD
STERILE CEFAZOLIN SODIUM BULK ANTIBIOTIC DRUG SUBSTANCE
26279
A
IV
7/31/2012
ABBOTT LABORATORIES HOSP PRODUCTS DIV
STD CONTROL PROCEDURES,RAW DRUG CODES FOR SVP & LVP PRODUCTS,5-80 5-81
26278
A
IV
7/27/2012
HERCULES INC
STAYBELITE RESIN
26300
A
IV
7/24/2012
ACS DOBFAR SPA
STERBAG(R) PACKAGING SYSTEM
26231
A
IV
7/13/2012
HALES & HUNTER
STANDARD OPERATING PROCEDS FOR MANUF MEDICATED FEEDS
26232
A
IV
7/13/2012
CARROLL CHEM CO DIV SPERTI DRUG CORP
STANDARD OPERATING PROCEDURE
26219
A
IV
7/11/2012
ICI AMERICAS INC
STANDARD DRUG MIXTURE #35--SDM#35
SULFASALAZINE
SUCROSE USP NF SUCROSE FATTY ACID ESTERS-SUCROSE STEARIC ACID ESTERS AND SUCROSE PALMITIC ACID ESTERS SUCRALFATE
Page 9
3Q2015 3Q2015EXCEL DMF# 26211
STATUS TYP SUBMIT DATE HOLDER E A IV 7/5/2012 DSM POLYMERS
SUBJECT
26212
A
IV
7/5/2012
BOREALIS AG
STAMYLEX 5119S
26220
A
IV
7/5/2012
ATLAS CHEMICAL INDUSTRIES INC
STANDARD DRUG MIXTURE NO. 16 (10% NITROGLYCERIN-LACTOSE MIXTURE)
26196
A
IV
7/3/2012
DSM POLYETHYLENES
STAMYLAN HD 7625
26188
A
IV
6/29/2012
MULTISORB TECHNOLOGIES INC
STABILOX CANISTER OXYGEN ABSORGING PRODUCTS
26157
A
IV
6/13/2012
HENRY H OTTENS MANUFACTURING CO INC
SPRAY DRIED NATURAL ORANGE FLAVOR WONF S-261
26168
A
IV
6/6/2012
ALDRICH CHEMICAL CO INC
SQUALENE
26119
A
IV
6/1/2012
FISONS CORP
SPINHALER, TORBO-INSUFFLATOR DEVICE
26120
A
IV
6/1/2012
DOW AGROSCIENCES LLC
SPINOSAD PHARMACEUTICAL GRADE
26054
A
IV
5/16/2012
RELIANCE LIFE SCIENCES PVT LTD
SORAFENIB TOSYLATE
26057
A
IV
5/14/2012
ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD
SORAFENIB TOSYLATE (VERSION NO.: 1)
26040
A
IV
5/8/2012
SIGMA F AND D DIV LTD
SOMATOSTATIN (PRODUCT NO. S 9129 FD)
25979
A
IV
5/5/2012
CREMER OLEO GMBH AND CO KG
SOFTISAN 378
26046
A
IV
5/3/2012
DM GRAHAM LABORATORIES INC
SOMOPHYLLIN CONTROLLED RELEASE THEOPHYLLINE 250MG
26069
A
IV
4/26/2012
GANES CHEMICALS INC PENNSVILLE DIV
SOTALOL HCL
25984
A
IV
4/23/2012
GLENMARK PHARMACEUTICALS LTD
SOLIFENACIN SUCCINATE
26092
A
IV
4/23/2012
MANE INC
SPEARMINT FLAVOR S.D. E_9822433
26093
A
IV
4/23/2012
SPEC, STANDARD CONTROL PROCEDS & TEXT METHODS FOR INACTIVE INGREDS.
26094
A
IV
4/23/2012
ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV BORMIOLI ROCCO E FIGLIO SPA PLASTIC DIV
25991
A
IV
4/20/2012
JUBILANT GENERICS LTD
SOLIFENACIN SUCCINATE
25967
A
IV
4/12/2012
CATALENT PHARMA SOLUTIONS LLC
SOFTGELS [OET-10275191]
25959
A
IV
4/10/2012
LA DREYFUS CO
SOFT IDEAL R BUBBLE GUM BASE AND NT CHEWING GUM BASE
25966
A
IV
4/10/2012
CATALENT PHARMA SOLUTIONS LLC
SOFTGELS [OET-00775174]
25975
A
IV
4/10/2012
CATALENT PHARMA SOLUTIONS LLC
SOFTGELS [OET-10275268]
26686
A
IV
4/8/2012
GUANDONG PHARMACEUTICAL FACTORY
SULFADIMETHOXINE SODIUM
25836
A
IV
4/1/2012
BASF CORP
SODIUM IBUPROFEN DIHYDRATE
25862
A
IV
3/9/2012
EUTICALS SPA
SODIUM MYCOPHENOLATE
25838
A
IV
2/29/2012
SYNCOR PHARMACEUTICALS INC
SODIUM IODIDE (I-123) SOLUTION
25832
A
IV
2/28/2012
SD FINE CHEM LTD
SODIUM HYDROXIDE PELLETS BP
25833
A
IV
2/28/2012
25824
A
IV
2/24/2012
CHONGQING SHENGHUAXI PHARMACEUTICAL CO SODIUM IBANDRONATE LTD NOVOZYMES AS SODIUM HYALURONATE FROM BACILLUS SUBTILIS (TOPICAL GRADE): HYASIS® 850T
25812
A
IV
2/15/2012
LG LIFE SCIENCES LTD
SODIUM HYALURONATE
25786
A
IV
2/14/2012
CARDINAL HEALTH 414 LLC
SODIUM FLUORIDE F18 INJECTION
25754
A
IV
2/3/2012
GENZYME FINE CHEMICALS
SODIUM CHOLESTERYL SULPHATE
25741
A
IV
1/28/2012
AKZONOBEL SALT AS
SODIUM CHLORIDE
25729
A
IV
1/23/2012
HOSPIRA HEALTHCARE INDIA PVT LTD
SODIUM CARBONATE (STERILE)
25708
A
IV
1/16/2012
TEVA PHARMACEUTICAL INDUSTRIES LTD
SODIUM ALENDRONATE
25691
A
IV
1/10/2012
ORGAMOL SA
SOBREROL
25699
A
IV
1/10/2012
MACCO ORGANIQUES INC
SODIUM ACETATE ANHYDROUS
STAMYLEX 2H 438
SPECIAL CHILD PROOF CAP 028MM
Page 10
3Q2015 3Q2015EXCEL DMF# 25739
STATUS TYP SUBMIT DATE HOLDER E A IV 1/10/2012 WHATMAN
SUBJECT
25755
A
IV
1/10/2012
25690
A
IV
1/9/2012
BURTON PARSONS AND CO INC
SOACLENS (SILICO) CONTACT LENS SOLUTION
25675
A
IV
12/30/2011
DAINIPPON SUMITOMO PHARMA CO LTD
SMP-028
25645
A
IV
12/27/2011
SKF 385 TRANYLCYPROMINE (VET)
25597
A
IV
12/13/2011
25566
A
IV
12/7/2011
SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP FOLIENWALZWERK BRUEDER TECH AKTIENGESELLSCHAFT CADILA HEALTHCARE LTD
25553
A
IV
12/1/2011
RIOCARE INDIA PVT LTD
SIMETHICONE EMULSION USP
25463
A
IV
11/3/2011
DOW CORNING CORP
SILASTIC QCF7-2856 ELASTOMER
25475
A
IV
10/31/2011
ZAKLADY FARMACEUTYCZNE POLPHARMA SA
SILDENAFIL CITRATE
25422
A
IV
10/25/2011
SHENG ZOU RUBBER AND PLASTICS
SHENG ZOU FORMULATION K02 (K02B) RUBBER STOPPER
25438
A
IV
10/25/2011
SYMED LABS LTD
SIBUTRAMINE HYDROCHLORIDE MONOHYDRATE
25429
A
IV
10/24/2011
MONTELL SDK SUNRISE LTD
SHOLEX 6002B AND SHO-ALLOMER MA 411 AND MA 422
25430
A
IV
10/24/2011
DOW CHEMICAL CO
SHORT TERM CHRONIC DIETARY FEEDING OF METHOCEL 2602 TO RATS
25704
A
IV
10/22/2011
AVANTOR PERFORMANCE MATERIALS INC
SODIUM ACETATE TRIHYDRATE
25416
A
IV
10/20/2011
Sheffield Tabletting System ODT
25413
A
IV
10/18/2011
25414
A
IV
10/18/2011
25415
A
IV
10/18/2011
25408
A
IV
10/13/2011
25395
A
IV
10/12/2011
KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE KERRY BIOFUNCTIONAL INGREDIENTS INC DBA KERRY BIO SCIENCE LIFE TECHNOLOGIES INC
25397
A
IV
10/12/2011
SONOCO FLEXIBLE PACKAGING
SFP003M-4 LAMINATED PACKAGING MATERIAL
25398
A
IV
10/12/2011
CHUGAI PHARMACEUTICAL CO LTD
SG-75 (N-(2-HYDROXYETHYL) NICOTINAMIDE NITRATE TABS
25377
A
IV
10/11/2011
LUPIN LTD
SEVELAMER HYDROCHLORIDE
25379
A
IV
10/10/2011
CHEMO IBERICA SA
SEVELAMER HYDROCHLORIDE
25369
A
IV
9/23/2011
NAVINTA LLC
SEVELAMER CARBONATE
25329
A
IV
9/21/2011
SHAILY ENGINEERING PLASTICS LTD
SEPL TOPICAL UNDERARM APPLICATOR
25330
A
IV
9/21/2011
TEMPIL DIV BIG THREE INDUSTRIES INC
SERIES 200 POLYMER ACTIVATED INKS
25332
A
IV
9/16/2011
NEWGEN BIOTECH INC
SERRAPEPTASE
25333
A
IV
9/16/2011
SPECIALTY ENZYMES AND BIOCHEMICALS CO
SERRATIOPEPTIDASE
25210
A
IV
8/12/2011
3M DRUG DELIVERY SYSTEMS
SCOTCHPAK(TM) 9680, 2-MIL POLYESTER FILM LAMINATE
25164
A
IV
7/26/2011
HETERO DRUGS LTD
SAXAGLIPTIN HYDROCHLORIDE PREMIX
25146
A
IV
7/19/2011
HETERO LABS LTD
SAQUINAVIR MESYLATE, USP
25139
A
IV
7/15/2011
EXXONMOBIL CHEMICAL CO
SANTOPRENE(TM) THERMOPLASTIC RUBBER 181-XXMED AND 281-XXMED GRADE SERIES
SODIUM CELLULOSE PHOSPHATE
REGENT BIO SCIENCE AND TECHNOLOGY CO LTD SODIUM CHONDROITIN SULFATE
SINGLE LAMINATED FOIL (FOIL, POLYETHYLENE) SIMVASTATIN ( LOVASTATIN ROUTE)
Sheffcoat White Sheffcoat White ENT SHEFFIELD BRAND MONOHYDRATE NF INHALATION 120MS Sheffcoat Clear ENT SF-900 SERUM-FREE INSECT CELL CULTURE MEDIUM
Page 11
3Q2015 3Q2015EXCEL DMF# 25403
STATUS TYP SUBMIT DATE HOLDER E A IV 7/11/2011 CAMBREX CHARLES CITY INC
SUBJECT SGD-1910
25112
A
IV
7/8/2011
PENINSULA LABS INC
SALMON CALCITONIN
25091
A
IV
6/20/2011
HUHTAMAKI OY LEIRAS PHARMACEUTICALS
SALBUTAMOL SULFATE BULK
25046
A
IV
6/9/2011
SABIC PETROCHEMICALS BV
SABIC LDPE 2200TC12
25019
A
IV
6/1/2011
ALBERMARLE CORP
S (+) IBUPROFEN
25004
A
IV
5/26/2011
AMINO CHEMICALS LTD
RUFINAMIDE USP
24985
A
IV
5/25/2011
WIMMER KG
RUBBER STOPPERS A-40 GREY FOR INFUSION BOTTLES
24966
A
IV
5/18/2011
PLASTICOID CO
RUBBER FORMULATIONS
24951
A
IV
5/16/2011
SCHUBERT SEALS AS
RUBBER COMPOUND NO. 6460
24952
A
IV
5/12/2011
LONSTROFF AG
RUBBER COMPOUNDS
24961
A
IV
5/9/2011
HELVOET PHARMA MARYLAND
RUBBER FORMULATION B5310-55 BLACK
24925
A
IV
5/5/2011
SCHUBERT SEALS AS
RUBBER COMPOUND 41010
24926
A
IV
5/4/2011
SCHUBERT SEALS AS
RUBBER COMPOUND 42018
24908
A
IV
4/27/2011
HELVOET PHARMA MARYLAND
RUBBER CLOSURE FORMULATON N4013-45 RED
24839
A
IV
4/8/2011
ROLLPRINT PACKAGING PRODUCTS INC
RPP#33-2023
24820
A
IV
4/1/2011
ROLLPRINT PACKAGING PRODUCTS INC
RPP #36-1210
24809
A
IV
3/31/2011
ROLLPRINT PACKAGING PRODUCTS INC
RPP #26-1066
24780
A
IV
3/18/2011
HEC PHARM CO LTD
ROSUVASTATIN CALCIUM NON-STERILE BULK DRUG SUBSTANCE
24759
A
IV
3/14/2011
CADILA HEALTHCARE LTD
ROSUVASTATIN CALCIUM
24711
A
IV
3/7/2011
TORRENT PHARMACEUTICALS LTD
ROPINIROLE HYDROCHLORIDE DRUG SUBSTANCE
24710
A
IV
3/4/2011
ORCHID CHEMICALS AND PHARMACEUTICALS LTD ROPINIROLE HYDROCHLORIDE (NON-STERILE BULK API)
24697
A
IV
2/27/2011
BASF AKTIENGESELLSCHAFT
RONFALIN SCF 34 WHITE 30265
24682
A
IV
2/25/2011
SHASUN CHEMICALS AND DRUGS LTD
ROFECOXIB
24379
A
IV
2/22/2011
EASTMAN KODAK CO
RHODAMINE 123
24380
A
IV
2/22/2011
ALDRICH CHEMICAL CO INC
RHODAMINE 123
24850
A
IV
2/16/2011
ELANCO PRODS DIV ELI LILLY AND CO
RS-1280 RESIDUALS IN LAYING CHICKENS (VET)
24851
A
IV
2/16/2011
ROCHE PALO ALTO LLC
RS-37619-00-31-3 (RS-37619, TROMETHAMINE SALT)
24853
A
IV
2/16/2011
SYNTEX USA INC
RS-44872-00-10-3 (d,l-1[2,4-dichloro-beta-[4-chlorobenzyl)thio]pheneth
24634
A
IV
2/12/2011
SMS PHARMACEUTICALS LTD
RIZATRIPTAN BENZOATE
24617
A
IV
1/28/2011
MACLEODS PHARMACEUTICALS LTD
RIVASTIGMINE TARTRATE
24566
A
IV
1/21/2011
CIPLA LTD
RITONAVIR USP
24576
A
IV
1/20/2011
RAKS PHARMA PVT LTD
RITONAVIR, USP (FORM-I)
24910
A
IV
1/12/2011
HELVOET PHARMA MARYLAND
RUBBER CLOSURE R2502-50 TAN
24785
A
IV
1/6/2011
PERRIGO API LTD
ROTIGOTINE
24514
A
IV
12/30/2010
GEDEON RICHTER LTD
RISPERIDONE
24488
A
IV
12/22/2010
CILAG AG
RIMANTADINE HYDROCHLORIDE
24492
A
IV
12/21/2010
ASPEN OSS BV
RIMEXOLONE
24464
A
IV
12/17/2010
MSN LABORATORIES PRIVATE LTD
RIFAXIMIN [ROUTE CODE "RX"]
24457
A
IV
12/15/2010
SANOFI AVENTIS SPA
RIFAXIMIN
24732
A
IV
12/15/2010
ROSELABS BIOSCIENCE LTD
ROSE-FILL-LT-2.25 ML (STERILE DISPOSABLE PRE-FILLABLE GLASS SYRINGES 2.25 ML)
Page 12
3Q2015 3Q2015EXCEL DMF# 24733
STATUS TYP SUBMIT DATE HOLDER E A IV 12/15/2010 ROSELABS BIOSCIENCE LTD
SUBJECT ROSE-FILL-LT-3.0 ML (STERILE DISPOSABLE PRE-FILLABLE GLASS SYRINGES 3.0 ML)
24734
A
IV
12/15/2010
ROSELABS BIOSCIENCE LTD
ROSE-FILL-LT-5.0 ML (STERILE DISPOSABLE PRE-FILLABLE GLASS SYRINGES 5.0 ML)
24735
A
IV
12/15/2010
ROSELABS BIOSCIENCE LTD
24736
A
IV
12/15/2010
ROSELABS POLYMERS LTD
ROSE-FILL-SN-1 M1 (STERILE PRE FILLABLE GLASS SYRINGES 1.0 ML WITH STACKED NEEDLE) ROSEPOLY FILL LT 1 ML (STERILE HYPODERMIC DISPOSABLE PREFILLABLE SYRINGE 1 ML)
24737
A
IV
12/15/2010
ROSELABS POLYMERS LTD
24738
A
IV
12/15/2010
ROSELABS POLYMERS LTD
ROSEPOLY FILL LT 2.25 ML (STERILE HYPODERMIC DISPOSABLE PREFILLABLE SYRINGE 2.25 ML) ROSEPOLY FILL LT 5 ML (STERILE HYPODERMIC DISPOSABLE PREFILLABLE SYRINGE 5 ML)
24739
A
IV
12/15/2010
MYLAN LABORATORIES LTD
ROSIGLITAZONE
24740
A
IV
12/15/2010
USV LIMITED
ROSIGLITAZONE MALEATE
24741
A
IV
12/15/2010
CIPLA LTD
ROSIGLITAZONE MALEATE
24742
A
IV
12/15/2010
SANDOZ PRIVATE LTD
ROSIGLITAZONE MALEATE
24743
A
IV
12/15/2010
ITF CHEMICAL LTDA
ROSIGLITAZONE MALEATE
24744
A
IV
12/15/2010
SMS PHARMACEUTICALS LTD
ROSIGLITAZONE MALEATE
24745
A
IV
12/15/2010
TEVA PHARMACEUTICALS INDUSTRIES LTD
ROSIGLITAZONE MALEATE
24455
A
IV
12/10/2010
RIFAXIMIN
24456
A
IV
12/10/2010
PHARMACEUTICAL FINE CHEMICALS PFC BAHAMAS LTD ZACH SYSTEM SPA
24459
A
IV
12/10/2010
LUPIN LTD
RIFAXIMIN
24729
A
IV
12/10/2010
ALDRICH CHEMICAL CO INC
ROSE BENGAL
24730
A
IV
12/10/2010
ALDRICH CHEMICAL CO INC
ROSE BENGAL, DISODIUM SALT, SIGMA-ALDRICH CHEMICAL CO. PRODUCT NUMBER W184-3
24731
A
IV
12/10/2010
ROSELABS BIOSCIENCE LTD
ROSE-FILL-LT-1.0 ML (STERILE DISPOSABLE PRE-FILLABLE GLASS SYRINGES 1.0 ML)
24431
A
IV
12/6/2010
MEDAREX INC
24440
A
IV
12/6/2010
24444
A
IV
12/6/2010
SICHUAN LONG MARCH PHARMACEUTICAL CO LTD LUPIN LTD
RICIN CONJUGATED MURINE MONOCLONAL ANTIBODY (MDX-RA) TO HUMAN LENS EPITHELIAL CELLS RIFAMPIN
24417
A
IV
12/1/2010
POLIMERI EUROPA FRANCE
RIBLENE MP20
24404
A
IV
11/29/2010
POLIMERI EUROPA SPA
RIBLENE FC20
24399
A
IV
11/24/2010
24389
A
IV
11/22/2010
PRIME EUROPEAN THERAPEUTICS SPA EUTICALS RIBAVIRIN USP-EP SPA BASF PHARMA EVIONNAZ SA RIBAVIRIN
24375
A
IV
11/15/2010
EI DUPONT DE NEMOURS AND CO INC
24357
A
IV
11/10/2010
CILAG AG
RETINAMIDIC ACID
24335
A
IV
11/1/2010
ROHM AND HAAS CO
RESINS - ION EXCHANGE AMBERLITE IRP 276 (CHOLESTYRAMINE RESIN USP)
24320
A
IV
10/27/2010
AMERICHEM INC
RESEARCH EXPERIMENT # 1192 (VET)
24390
A
IV
10/26/2010
YAMASA CORP
RIBAVIRIN
24391
A
IV
10/26/2010
BIDACHEM SPA
RIBAVIRIN
24392
A
IV
10/26/2010
EUTICALS SPA
RIBAVIRIN
24293
A
IV
10/15/2010
ZAKLADY FARMACEUTYCZNE POLPHARMA SA
REPAGLINIDE
RIFAXIMIN
RIFAMPIN USP
RHENIUM-186 AS SODIUM PERRHENATE (NaRe04)
Page 13
3Q2015 3Q2015EXCEL DMF# 24294
STATUS TYP SUBMIT DATE HOLDER E A IV 10/15/2010 MACLEODS PHARMACEUTICALS LTD
SUBJECT
24295
A
IV
10/15/2010
JUBILANT GENERICS LTD
REPAGLINIDE
24265
A
IV
10/4/2010
RELIANCE INDUSTRIES LTD
RELPET G5801
24212
A
IV
9/24/2010
ALABAMA FLOUR MILLS
RED HAT BROILER CONCENTRATE NON-MEDICATED FEEDS
24187
A
IV
9/16/2010
JIANGXI SYNERGY PHARMACEUTICAL CO LTD
REBAMIPIDE
24141
A
IV
9/14/2010
TAI HENG INDUSTRY CO LTD
RASAGILINE MESYLATE
24142
A
IV
9/14/2010
EVERLIGHT CHEMICAL INDUSTRIAL CORP
RASAGILINE MESYLATE
24166
A
IV
9/10/2010
VETROPACK LTD
RAW MATERIALS AND
24138
A
IV
9/6/2010
ALKEM LABORATORIES LTD
RASAGILINE MESYLATE
24122
A
IV
8/30/2010
MSN PHARMACHEM PRIVATE LTD
RANOLAZINE [ROUTE CODE - "RL"]
24099
A
IV
8/27/2010
FAKO ILACLARI AS
RANITIDINE HYDROCHLORIDE FORM II
24111
A
IV
8/25/2010
HEUMANN PHARMA GMBH AND CO
RANITIDINE HYDROCHLORIDE-FORM 1
24094
A
IV
8/23/2010
NEULAND LABORATORIES LTD
RANITIDINE HYDROCHLORIDE (FORM I)
24092
A
IV
8/16/2010
UNION QUIMICO FARMACEUTICA SA UQUIFA SA
RANITIDINE HYDROCHLORIDE (CRYSTALLINE FORM)
24065
A
IV
8/15/2010
APOTEX PHARMACHEM INDIA PVT LTD
RAMIPRIL USP
24150
A
IV
8/13/2010
PAR ACTIVE TECHNOLOGIES PRIVATE LTD
RASAGILINE MESYLATE (NON STERILE BULK DRUG SUBSTANCE)
24384
A
IV
8/12/2010
ROHM AND HAAS CO
RHOZYME J-25 CONCENTRATE
24037
A
IV
8/2/2010
CAMBREX PROFARMACO MILANO SRL
RALOXIFENE HYDROCHLORIDE
24001
A
IV
7/27/2010
STUDSVIK ISOTOPSERVICE AB
RADIOACTIVE XENON-133 GAS
24010
A
IV
7/27/2010
IMAGENTS INC
RADIOCHEMICAL THALLOUS CHLORIDE TL-201
24011
A
IV
7/27/2010
ATOMIC ENERGY OF CANADA LTD
RADIOISOTOPE MASTER FILE
24006
A
IV
7/25/2010
IMAGENTS INC
RADIOCHEMICAL GALLIUM CITRATE Ga-67
23970
A
IV
7/4/2010
AUROBINDO PHARMA LTD
RABEPRAZOLE SODIUM
23938
A
IV
7/2/2010
PT KIMIA FARMA PERSERO TBK
QUININE HYDROCHLORIDE
23950
A
IV
7/1/2010
REXAM CONSUMER PLASTICS INC
23917
A
IV
6/25/2010
SOCIETE CHIMIQUE POINTET GIRARD SA
QVAR (BERCLOMETHASONE DIPROPIONATE HFA) INHALATION AEROSOL ACTUATORS AND DUST CAP QUINIDINE GLUCONATE
23919
A
IV
6/25/2010
SCHERING AG
QUINIDINE GLUCONATE
23928
A
IV
6/23/2010
KIMIA FARMA
QUINIDINE SALTS
23912
A
IV
6/21/2010
ISLAND CHEMICAL CO INC
QUINIDINE AND QUINIDINE SALTS
23874
A
IV
6/9/2010
TEVA PHARMACEUTICAL INDUSTRIES LTD
QUETIAPINE FUMARATE
23882
A
IV
6/9/2010
RANBAXY LABORATORIES LTD
QUETIAPINE FUMARATE (NON-STERILE BULK)
23869
A
IV
6/7/2010
SYNKEM SAS
QUETIAPINE FUMARATE
23816
A
IV
5/15/2010
SIGMA F AND D DIV LTD
PYRUVIC ACID SODIUM SALT
23812
A
IV
5/12/2010
FUKUZYU PHARMACEUTICAL CO LTD
PYRIMETHAMINE
23733
A
IV
5/7/2010
PUURS ASEPTIC MANUFACTURING FACILITY
23781
A
IV
4/30/2010
PHARMACIA AND UPJOHN CO WHOLLY OWNED SUB PFIZER INC DELMAR CHEMICALS INC
23750
A
IV
4/23/2010
LAMP S PROSPERO SPA
PVC FOIL DRUG PACKAGING MATERIAL LAMINATED TO PE FILM
23751
A
IV
4/23/2010
BORDEN CHEM CO
PVC HOMOPOLYMER RESINS
23720
A
IV
4/16/2010
NOVO NORDISK AS
PURIFIED INSULIN
REPAGLINIDE
PYRAZINAMIDE
Page 14
3Q2015 3Q2015EXCEL DMF#
SUBJECT
23713
STATUS TYP SUBMIT DATE HOLDER E A IV 4/9/2010 PUREPLAST INC
23714
A
IV
4/9/2010
STEROGENE BIOSEPARATIONS INC
PURIFICATION CHROMATOGRAPHY MEDIA USED IN THE PREPARATION OF PROTEINS
23698
A
IV
4/7/2010
BASELL POLYOLEFINE ITALIA SRL
PURELL ACP 6541 A (POLYETHYLENE HIGH DENSITY)
23692
A
IV
4/6/2010
WINPAK FILMS INC
PUREFLEX FILM
23703
A
IV
4/6/2010
BASELL POLYOLEFINE ITALIA SRL
PURELL PE 2420 F
23677
A
IV
3/26/2010
TAISEI KAKO CO LTD
PTP-SHEETS FOR PKG. TABLETS AND CAPSULES
23706
A
IV
3/22/2010
BASELL POLIOLEFINE ITALIA SRL
PURELL PE 3040 D
23571
A
IV
3/16/2010
ROCHE DIAGNOSTICS GMBH
PROPYLTHIOURACIL
23613
A
IV
3/8/2010
ABBOTT LABORATORIES
PROTIRELIN (TRH)
23602
A
IV
3/1/2010
KV PHARMACEUTICAL CO
PROTECTIVE CREAMS,LOTIONS-WESTPORT FACIL. ON SCHUETZ RD, ST. LOUIS, MO
23529
A
IV
2/15/2010
SIEGFRIED USA INC
PROPOXYPHENE HYDROCHLORIDE
23481
A
IV
1/20/2010
PHARMAZELL GMBH
PROPAFENONE HYDROCHLORIDE
23420
A
IV
12/18/2009
PRO-FAX RP512H POLYPROPYLENE COPOLYMER RESIN
23363
A
IV
12/7/2009
EQUISTAR CHEMICALS LP A LYONDELLBASELL INDUSTRIES CO WEDTECH INC
23364
A
IV
12/7/2009
WEDTECH INC
PRODUCT CODE 1006 WHITE FOR USE IN PACKAGING MATERIALS
23334
A
IV
12/3/2009
FONA INTERNATIONAL INC
PRODUCT # 889.0069U PEACH FLAVOR, NAT WONF
23290
A
IV
11/20/2009
ACIC LTD
PROCEDURES FOR THE MANUF OF THIORIDAZINE HCL
23257
A
IV
11/12/2009
CHEMSPEC API
PROCARBAZINE HYDROCHLORIDE
23259
A
IV
11/12/2009
HOFFMANN LA ROCHE INC
PROCARBAZINE HYDROCHLORIDE PARENTERAL
23260
A
IV
11/12/2009
APICORE US LLC
PROCARBAZINE HYDROCHLORIDE USP
23258
A
IV
11/11/2009
CHEMPACIFIC CORP
PROCARBAZINE HYDROCHLORIDE (DRUG SUBSTANCE)
23261
A
IV
11/11/2009
CATALENT PHARMA SOLUTIONS LLC
PROCARDIA SOFTGELS 10 MG (NIFEDIPINE)
23221
A
IV
10/29/2009
DMV FONTERRA EXCIPIENTS GMBH CO KG
PRIMOJEL (NA STARCH GLYCOLATE)
23218
A
IV
10/23/2009
NANTONG JINGHUA PHARMACEUTICAL CO LTD
PRIMIDONE
23187
A
IV
10/16/2009
APICORE US LLC
PRIMAQUINE PHOSPHATE, USP
23149
A
IV
10/6/2009
DIOSYNTH BV
PREGNENOLONE HEMISUCCINATE
23152
A
IV
9/29/2009
IMUTEC CORP
PREMIX A FOR VIRULIZIN-2B
23112
A
IV
9/9/2009
SUN PHARMACEUTICAL INDUSTRIES LTD
PREGABALIN
23113
A
IV
9/9/2009
CHANGZHOU PHARMACEUTICAL FACTORY
PREGABALIN
23111
A
IV
9/8/2009
ALPHAPET INC
PREFORMANCE® PET 1708CC(A)
23086
A
IV
9/2/2009
COMPANIA ESPANOLA DE SINTESIS QUIMICA SA
PREDNISOLONE SODIUM PHOSPHATE, USP XX
23087
A
IV
9/2/2009
DIOSYNTH BV
PREDNISOLONE SUCCINATE
23099
A
IV
8/31/2009
CRYSTAL PHARMA SAU
PREDNISONE ANHYDROUS USP,
23053
A
IV
8/13/2009
WINPAK TECHNOLOGIES INC
PRECLINICAL TOXICOLOGY DATA FOR THE AGENT ECTEINASCIDIN 743 IN BETHESDA, MD
23025
A
IV
8/10/2009
PROSINTEX INDUSTRIE CHIMIQUE ITALIANE SRL
PRAZOSIN HYDROCHLORIDE
23026
A
IV
7/29/2009
FERMION OY
PRAZOSIN HYDROCHLORIDE
23027
A
IV
7/29/2009
PRAZOSIN HYDROCHLORIDE
22988
A
IV
7/27/2009
CHEMICAL PHARMACEUTICAL RESEARCH INSTITUTE NIHFI LTD AUROBINDO PHARMA LTD
PRASUGREL HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE)
22989
A
IV
7/22/2009
MSN LABORATORIES PRIVATE LTD
PRASUGREL HYDROCHLORIDE [ROUTE CODE - "PR"]
PURETHERM 100C AND PURETHERM 1001C WHITE PVC FILMS
PRODUCT CODE 1004 WHITE
Page 15
3Q2015 3Q2015EXCEL DMF# 22965
STATUS TYP SUBMIT DATE HOLDER E A IV 7/20/2009 SYN-TECH CHEM AND PHARM CO LTD
SUBJECT PRAMOXINE HYDROCHLORIDE, USP
22948
A
IV
7/15/2009
AUROBINDO PHARMA LTD
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
22891
A
IV
6/18/2009
RN LABORATORIES PVT LTD
POVIDONE IODINE USP
22848
A
IV
6/10/2009
ZHUHAI UNITED LABORATORIES CO LTD
POTASSIUM CLAVULANATE DILUTED WITH SILICON DIOXIDE IN THE RATIO 1:1
22849
A
IV
6/3/2009
22850
A
IV
6/3/2009
SHANDONG NEW TIME PHARMACEUTICAL CO LTD POTASSIUM CLAVULANATE, DILUTED WITH MICROCRYSTALLINE CELLULOSE IN THE RATIO 1:1 SHANDONG NEW TIME PHARMACEUTICAL CO LTD POTASSIUM CLAVULANATE, DILUTED WITH SILICON DIOXIDE IN THE RATIO 1:1
22803
A
IV
5/26/2009
CHEMI SPA
22815
A
IV
5/26/2009
3M
POROUS MEMBRANE TAPE
22821
A
IV
5/22/2009
WUHAN ZY PHARMACEUTICAL CO LTD
POSACONAZOLE
22822
A
IV
5/22/2009
SANDOZ PRIVATE LTD
POSACONAZOLE
22778
A
IV
5/14/2009
NAN YA PLASTICS CORP
POLYVINYL CHLORIDE (PVC) PELLETS, MEDICAL GRADE
22804
A
IV
5/7/2009
CHEMI SPA
POPC(1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-PHOSPHORYLCHOLINE)
22734
A
IV
4/16/2009
22719
A
IV
4/14/2009
ANHUI HUAFENG PHARMACEUTICAL RUBBER CO LTD RELIANCE INDUSTRIES LTD
POLYPROPYLENE THERMOPLASTIC ELASTOMER COMBINATION CAP FOR PLASTIC CONTAINERS FILLED WITH AQUEOUS PARENTERAL PREPARATIONS POLYPROPYLENE RAW MATERIAL REPOL H200MK
22769
A
IV
4/7/2009
WESTROCK SLATERSVILLE LLC
POLYTOP AND POLYCAM CLOSURES
22662
A
IV
3/25/2009
HUNTSMAN CHEMICAL CORP
POLYPROPYLENE
22657
A
IV
3/23/2009
MITSUI NORIN CO LTD
POLYPHENON E (USAN: SINECATECHINS)
22660
A
IV
3/18/2009
LCY CHEMICAL CORP
POLYPROPLENE POLYMERS: PT231M, ST612, STM866, ST757M, ST868M, PT100 and 8461
22635
A
IV
3/17/2009
ALUMINUM CO AMERICA
POLYMERIC HEAT-SEAL COATED ALUMINUM FOIL 9403, 9404, AND 9405
22591
A
IV
3/4/2009
NOVA CHEMICALS CORP
POLYETHYLENE RESINS
22569
A
IV
2/23/2009
POLYETHYLENE GLYCOL 6000
22567
A
IV
2/20/2009
TIANJIN BOKELIN MEDICAL PACKAGING TECHNOLOGY CO LTD PLANET SCIENCE
22593
A
IV
2/19/2009
DOW CHEMICAL CO
POLYETHYLENE RESINS FOR PACKAGING AND MEDICAL APPLICATIONS
22516
A
IV
2/10/2009
ST GOBAIN PERFORMANCE PLASTICS
POLYESTER FILM C/1/S WITH 8005 SILICONE RELEASE COATING
22467
A
IV
1/22/2009
SCIENTIFIC POLYMER PRODUCTS INC
POLY (2-HYDROXYETHYL METHACAYLATE)
22466
A
IV
1/21/2009
INEOS OLEFINS AND POLYMERS USA
POLPROPYLENE RESINS-GENERAL FORMULATIONS
22604
A
IV
1/19/2009
INVISTA RESINS AND FIBERS GMBH
POLYETHYLENE TEREPHTHALATE RESINS USED IN PACKAGING
22428
A
IV
1/7/2009
PLIANT CORP
PLIANT 105.1T POLYETHYLENE SHEETING FILM
22518
A
IV
1/7/2009
RHODIA INDUSTRIAL YARNS AG
POLYESTER GRANULAT 74K40
22519
A
IV
1/7/2009
RHODIA INDUSTRIAL YARNS AG
POLYESTER GRANULAT 74K40Z108
22315
A
IV
12/17/2008
22298
A
IV
12/12/2008
BPREX HEALTHCARE PACKAGING INC DBA BERRY PLASTIC CONTAINERS PLASTICS REXAM PHARMA PACKAGING INDIA PVT LTD PLASTIC CONTAINER & CLOSURES FOR ORAL PREPARATION
22292
A
IV
12/10/2008
COMAR LLC
22212
A
IV
10/27/2008
AH ROBINS CO
PLANT MASTER FILE FOR ARECIBO, PUERTO RICO LOCATION
22114
A
IV
10/17/2008
ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD
PIOGLITAZONE HYDROCHLORIDE USP
22091
A
IV
10/15/2008
BIOCON LTD
PIOGLITAZONE HYDROCHLORIDE
22075
A
IV
10/10/2008
PAR PHARMACEUTICAL INC
PIMOZIDE USP
POPC POSITIONAL PURITY 95%
POLYETHYLENE GLYCOL 400 MONOSTEARATE (P1154)
PLASTIC CLOSURES
Page 16
3Q2015 3Q2015EXCEL DMF#
21882
STATUS TYP SUBMIT DATE HOLDER E A IV 8/29/2008 AMSA ANONIMA MEDICINALI SINTETICI & AFFINI SPA A IV 8/15/2008 SIEGFRIED USA LLC
PHENOBARBITAL AND PHENOBARBITAL SODIUM USP
21846
A
IV
8/1/2008
VERSALIS SPA
PHARMALENE FL 20 PH
21847
A
IV
8/1/2008
VERSALIS SPA
PHARMALENE MP 20 PH
21854
A
IV
7/30/2008
DMV FONTERRA EXCIPIENTS GMBH CO KG
PHARMATOSE(R) DCL 21
21871
A
IV
7/28/2008
KV PHARMACEUTICAL CO
PHENDIMETRAZINE TARTRATE SUSTAINED RELEASE CAPSULES 100 MG.
21817
A
IV
7/23/2008
BEACON CONVERTERS INC
PHARMACEUTICAL PACKAGING MATERIAL
21784
A
IV
7/11/2008
SPI PHARMA INC
PHARMABURST® B SERIES PRODUCTS
21760
A
IV
6/30/2008
VICTOR M HERMELIN CO DIV K-V PHARMACAL CO PETN - BUTABARBITAL
21783
A
IV
6/25/2008
SPI PHARMA INC
PHARMABURST(TM) C1
21685
A
IV
6/6/2008
SYNCOR INTERNATIONAL CORP
PERSONNEL, FACILITIES & GENERAL OPERATING PROCEDURES-GLENDALE CA PLANT
21656
A
IV
6/3/2008
APICORE US LLC
PERPHENAZINE USP
21638
A
IV
5/19/2008
CELSUS LABORATORIES INC
PERIODATE-OXIDIZED HEPARIN
21632
A
IV
5/16/2008
MYLAN LABORATORIES LTD
PERINDOPRIL TERT-BUTYLAMINE
21618
A
IV
5/15/2008
BACHEM SA
PERGOLIDE MESYLATE
21647
A
IV
5/14/2008
SRIKEM LABORATORIES PVT LTD
PERMETHRIN
21596
A
IV
5/7/2008
ALDRICH CHEMICAL CO INC
PERCORTEN PIVALATE
21597
A
IV
5/7/2008
FLUOROMED LP
PERFLUORO(T-BUTYCYCLOHEXANE),96.0%(TRADE NAME APF-150M)
21598
A
IV
5/7/2008
F2 CHEMICAL LTD
PERFLUOROBUTANE
21600
A
IV
5/7/2008
EI DUPONT DE NEMOURS AND CO INC
PERFLUOROCTYLBROMIDE
21599
A
IV
5/6/2008
F2 CHEMICALS LTD
PERFLUOROBUTANE
21601
A
IV
5/6/2008
ELF ATOCHEM NORTH AMERICA INC
PERFLUORODECYL BROMIDE C10F21BR
21550
A
IV
4/18/2008
CHEMISCHE FABRIK BERG GMBH
PENTOBARBITAL SODIUM USP
21516
A
IV
4/4/2008
INTERNATIONAL MINERALS & CHEMICAL CORP
PENTAERYTHRITOL (PETN)
21431
A
IV
3/10/2008
SMS PHARMACEUTICALS LTD
PENCICLOVIR
21403
A
IV
3/7/2008
SHILPA MEDICARE LTD
PEMETREXED DIPOTASSIUM (NONA HYDRATE) (PMN)
21453
A
IV
3/6/2008
SMITHKLINE BEECHAM PHARMACEUTICALS
PENICILLIN G POTASSIUM
21435
A
IV
3/5/2008
WANBURY LTD
PENICILLAMINE
21352
A
IV
2/15/2008
KANEKA CORP
PCE
21312
A
IV
2/5/2008
ZACH SYSTEM SA
PAROXETINE STAGE 2 DL-AMINO ALCOHOL
21266
A
IV
1/18/2008
PENINSULA LABS INC
PARATHYROID HORMONE (HUMAN),1-34
21225
A
IV
1/4/2008
DAIICHI PHARMACEUTICAL CO LTD
PANTOSIN 200 MG TABLETS
21198
A
IV
12/28/2007
LUPIN LTD
PANTOPRAZOLE SODIUM SESQUIHYDRATE
21029
A
IV
11/11/2007
PHYTOGEN LIFE SCIENCES INC
PACLITAXEL
21014
A
IV
11/2/2007
FRESENIUS USA INC
PACKAGING OF SVP AND LVP PRODUCTS IN OGDEN, UTAH
20986
A
IV
10/22/2007
WATSON LABORATORIES INC
PACKAGING MATERIALS AS MANFACTURED IN COPIAGUE, NY.
20956
A
IV
10/11/2007
TECHNICOTE
PACKAGING MATERIALS
20960
A
IV
10/11/2007
PARM PRECISION PLASTICS
PACKAGING MATERIALS
20954
A
IV
10/10/2007
TENAX CORP
PACKAGING MATERIALS
21922
SUBJECT PHENYLBUTAZONE
Page 17
3Q2015 3Q2015EXCEL DMF# 20955
STATUS TYP SUBMIT DATE HOLDER E A IV 10/10/2007 RICHARDS PACKAGING INC
SUBJECT PACKAGING MATERIALS
20922
A
IV
10/9/2007
HOFFMANN LA ROCHE INC
PACKAGING MATERIALS
20887
A
IV
9/26/2007
HYUNDAI ENGINEERING PLASTICS CO LTD
PACKAGING MATERIAL
20915
A
IV
9/25/2007
BOREALIS AS
PACKAGING MATERIAL NCPE 7003 AND NCPE 7007
20693
A
IV
9/19/2007
JUZEN CHEMICAL CORP
OXYBUTYNIN
19694
A
IV
8/31/2007
SB PENICK AND CO
NEOMYCIN SULFATE USP
20834
A
IV
8/24/2007
DELCOR LABORATORIES INC
PACKAGING FACILITY LOCATED IN E. STROUDSBURG, PA
20772
A
IV
8/13/2007
DIASPA TRADE MARK STRIDES ITALIA SRL
OXYTETRACYCLINE HYDROCHLORIDE
20762
A
IV
8/6/2007
CHEMIBIOTIC IRELAND LTD
OXYTETRACYCLINE
20732
A
IV
7/30/2007
CENTER MOLECULAR RESEARCH LLC
OXYGEN-18 ENRICHED WATER
20668
A
IV
6/19/2007
ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD
OXCARBAZEPINE
20585
A
IV
6/7/2007
NATIONAL INSTITUTES HEALTH NATIONAL CANCER INSTITUTE DIV CANCER PREVENTION AND CONTROL
OVERSIGHT, REVIEW, MONITORING AND AUDITING PROCEDURES OF NCI, DCPD IN BETHESDA, MD.
20601
A
IV
6/5/2007
PARABOLIC DRUGS LTD
OXACILLIN SODIUM USP
20588
A
IV
6/4/2007
AUROBINDO PHARMA LTD
OXACILLIN FOR INJECTION USP (STERILE BULK)
20537
A
IV
5/14/2007
ORGANON OSS
ORGABOLIN TABLETS 2 MG.
20526
A
IV
5/11/2007
FLAVOR AND FRAGRANCE SPECIALTIES INC
ORANGE FL N&A #221P52
20527
A
IV
5/11/2007
TASTEMAKER
ORANGE FLAV-O-LOK (MM 3X 610047)
20568
A
IV
5/10/2007
RHONE POULENC INC
ORUVAIL 200 MG. CAPSULES
20599
A
IV
5/7/2007
OXACILLIN SODIUM STERILE CRYSTALLINE (BULK)
20507
A
IV
5/3/2007
ISTITUTO BIOCHIMICO ITALIANO GIOVANNI LORENZINI PENICK CORP
20497
A
IV
4/24/2007
ARCHIMICA SPA
OP 3300/15
20389
A
IV
3/30/2007
EUTICALS INC
OMEGA-3 ACID ETHYL ESTERS DRUG SUBSTANCE
20348
A
IV
3/8/2007
APOTEX PHARMACHEM INDIA PVT LTD
OLMESARTAN MEDOXOMIL USP
20329
A
IV
3/6/2007
DR REDDYS LABORATORIES LTD
OLMESARTAN MEDOXOMIL
20279
A
IV
2/5/2007
ACS DOBFAR SPA
O-FORMYL CEFAMANDOLE ACETONITRILE SOLVATE
20221
A
IV
1/31/2007
KIRCHNER SIMON AND CO GMBH
20233
A
IV
1/31/2007
20217
A
IV
1/23/2007
DISHMAN PHARMACEUTICALS AND CHEMICALS LTD LEDERLE LABORATORIES
O28L89070 TAMPER EVIDENT CAP PP 28 WITH HOLE 5 MM MADE OF PP WHITE WITH TAMPER EVIDENT RING MADE OF PP BLUE AND INJECTED JOINT MADE OF TPE OCTENIDINE HYDROCHLORIDE
20216
A
IV
1/15/2007
ANTIBIOTICE SA
NYSTATIN
20156
A
IV
1/12/2007
BASF AKTIENGESELLSCHAFT
NOVOLEN 1325 M
20139
A
IV
1/9/2007
GC CHEMIE PHARMIE LTD
NOVODONE-CR CROSPOVIDONE USP-34
20084
A
IV
12/22/2006
NV ORGANON
NORGESTOMET
19954
A
IV
10/30/2006
G POHL BOSKAMP GMBH AND CO KG
NITRONEL-GEL
19864
A
IV
10/13/2006
SUMIKA FINE CHEMICALS CO LTD
NIFEDIPINE USP XX
19820
A
IV
10/2/2006
LABORATORIOS HAYMANN SA
NICOTINE POLACRILEX USP , 20%
19821
A
IV
10/2/2006
CAMBREX CHARLES CITY INC
NICOTINE POLACRILEX, 15%, USP
OPIUM TINCTURE SOLUTION
NYSTATIN BULK POWDER
Page 18
3Q2015 3Q2015EXCEL DMF#
19767
STATUS TYP SUBMIT DATE HOLDER SUBJECT E A IV 9/28/2006 JOHNSON AND JOHNSON CONSUMER INC MCNEIL NICOTINE OROMUCOSAL SPRAY CONSUMER HEALTHCARE DIVISION A IV 9/11/2006 BACHEM FEINCHEMIKALIEN AG N-FMOC-L-LEUCINE SODIUM SALT
19731
A
IV
8/31/2006
INJECTA AMPOULES PVT LTD
19704
A
IV
8/18/2006
MEIJI SEIKA KAISHA LTD
NEOTHRAMYCIN, BULK
19706
A
IV
8/18/2006
CARBOGEN AMCIS AG
NEPAFENAC
19699
A
IV
8/16/2006
HOFFMANN LA ROCHE INC
NEOSTIGMINE METHYLSULFATE
19664
A
IV
7/31/2006
ISOCHEM SAS
NEFOPAM HYDROCHLORIDE
19665
A
IV
7/31/2006
CHEMAGRO CORP
NEGUVON
19666
A
IV
7/31/2006
ALP PHARM BEIJING CO LTD
NELARABINE
19667
A
IV
7/31/2006
GANES CHEMICALS INC PENNSVILLE DIV
NELFINAVIR
19946
A
IV
7/26/2006
SOCIETE SUISSE DES EXPLOSIFS
NITROGLYCERIN,PENTAERYTHRITOL TETRANITRATE AND ISOSORBIDE DINITRATE
19640
A
IV
7/20/2006
SYNTHETIC FERTILIZERS AND CHEMICALS INC
N-DIETHYLVANILLAMIDE (MFR. & SPECS)
19653
A
IV
7/4/2006
HONOUR LAB LTD
NEBIVOLOL HYDROCHLORIDE
19577
A
IV
7/3/2006
KERRY INGREDIENTS AND FLAVOURS
NATURAL BANANA FLAVOR WONF 080-0029R LIQUID
19538
A
IV
6/20/2006
HENRY H OTTENS MANUFACTURING CO INC
NATURAL & ARTIFICIAL CITRUS FLAVOR # 9185
19530
A
IV
6/13/2006
CADILA PHARMACEUTICALS LTD
NATEGLINIDE FORM H USP
19520
A
IV
5/24/2006
UNGERER AND CO
NAT/ART MANGO FLVP FV-658
19453
A
IV
5/22/2006
FUKUZYU PHARMACEUTICAL CO LTD
NAPHAZOLINE HYDROCHLORIDE
19439
A
IV
5/16/2006
MALLINCKRODT INC
NALTREXONE METHOBROMIDE
19430
A
IV
5/5/2006
CILAG AG
NALTREXONE DRUG SUBSTANCE
19353
A
IV
4/14/2006
IPCA LABORATORIES LTD
NABUMETONE USP, PROCESS II
19354
A
IV
4/14/2006
ZHEJIANG SHENZHOU PHARMACEUTICAL CO LTD NABUMETONE(BULK)
19355
A
IV
4/14/2006
SICOR SPA
N-ACETYL CALICHEAMICIN
19363
A
IV
4/14/2006
ALDRICH CHEMICAL CO INC
N-ACETYL-DL-PENICILLAMINE
19358
A
IV
4/12/2006
SIEGFRIED AG
N-ACETYL PROCAINAMIDE HCL
19359
A
IV
4/12/2006
PHARMAZELL INDIA PRIVATE LTD
N-ACETYL TYROSINE
19360
A
IV
4/12/2006
NIPPON PROTEIN CO LTD
N-ACETYL-D-GLUCOSAMINE
19361
A
IV
4/12/2006
PFANSTIEHL LABORATORIES INC
N-ACETYL-D-GLUCOSAMINE
19346
A
IV
4/7/2006
ERREGIERRE SPA
NABUMETONE
19304
A
IV
4/4/2006
NANOSYSTEMS
N1106 (VX-745) ORAL NANOCRYSTAL CAPSULES (125MG)
19348
A
IV
4/3/2006
API INC
NABUMETONE DRUG SUBSTANCE
19298
A
IV
3/28/2006
ERREGIERRE SPA
N-[4-(TRIFLUOROMETHYL)BENZYL]-4-METHOXYBUTYRAMIDE
19275
A
IV
3/20/2006
UNGERER AND CO
N/A CHERRY BERRY FL FM-4725
19276
A
IV
3/20/2006
UNGERER AND CO
N/A CHERRY FLAVOR FV-7379
19277
A
IV
3/20/2006
UNGERER AND CO
N/A CHERRY FLVP FLAVOR WS FO-1979
19278
A
IV
3/20/2006
UNGERER AND CO
N/A COUGH SYRUP MASKER FLAVOR FN-6819
19221
A
IV
3/3/2006
OLON SPA
MYCOPHENOLIC ACID NS TECHNICAL GRADE
19193
A
IV
2/15/2006
EMCURE PHARMACEUTICALS LTD
MYCOPHENOLATE MOFETIL USP
19184
A
IV
2/10/2006
LEK PHARMACEUTICALS DD
MYCOPHENOLATE MOFETIL (ACTIVE SUBSTANCE)
19811
NEUTRAL GLASS AMPOULES USP TYPE I
Page 19
3Q2015 3Q2015EXCEL DMF# 19150
STATUS TYP SUBMIT DATE HOLDER E A IV 2/3/2006 BAXTER HEALTHCARE CORP
SUBJECT MURINE MONOCLONAL ANTIBODIES (ANTI-CD8/CD4) TO HUMAN T-CELLS
19144
A
IV
1/30/2006
TEVA PHARMACEUTICAL INDUSTRIES LTD
MUPIROCIN CALCIUM DIHYDRATE
19244
A
IV
1/20/2006
FLAVORMATIC INDUSTRIES INC
N&A GRAPE TYPE FLAVOR #909-510
19245
A
IV
1/20/2006
UNGERER AND CO
N&A MENTHOL FLVP FN-6067
19246
A
IV
1/20/2006
UNGERER AND CO
N&A PEPPERMINT FLVP FN-6243
19042
A
IV
12/19/2005
MSN PHARMACHEM PRIVATE LTD
MONTELUKAST SODIUM USP [ROUTE CODE - MT"]
18925
A
IV
11/1/2005
PAR ACTIVE TECHNOLOGIES PRIVATE LTD
MOLINDONE HYDROCHLORIDE
19102
A
IV
10/28/2005
NEOMPS INC
MPS-69 (SYNTHETIC PEPTIDE)
19103
A
IV
10/28/2005
INTERNATIONAL SPECIALTY PRODUCTS
M-PYROL (N-METHYLPYRROLIDONE)
18895
A
IV
10/21/2005
ORCHID CHEMICALS AND PHARMACEUTICALS LTD MODAFINIL
19165
A
IV
10/20/2005
IMMUNOMEDICS INC
18881
A
IV
10/15/2005
MEYERS COLOUR COMPOUNDS LTD
MURINE MONOCLONAL ANTIBODY AND F(AB)2 FRAGMENT (IMMU-14) TO CARCINOEMBRYONIC ANTIGEN (CEA) MMB-3479 GREY & MMB-7366 MAUVE
18863
A
IV
10/11/2005
DAIICHI PURE CHEMICALS CO LTD
MIX-RR
18830
A
IV
10/4/2005
EVERLIGHT CHEMICAL INDUSTRIAL CORP
MISOPROSTOL
18875
A
IV
9/22/2005
IHARA CHEMICAL INDUSTRY CO LTD
MKS-1 (AN INTERMEDIATE OF GATIFLOXACIN)
18784
A
IV
9/19/2005
UNION QUIMICO FARMACEUTICA SA UQUIFA SA
MINOCYCLINE HYDROCHLORIDE USP
18795
A
IV
9/19/2005
ALLERGAN OPTICAL INC DIV ALLERGAN INC
MIOGAN (ACETYLCHOLINE CHLORIDE FOR OPTHALMIC SOLUTION)
18796
A
IV
9/19/2005
PCAS
MIPRI
18773
A
IV
9/12/2005
LEDERLE LABORATORIES
MINOCYCLINE HYDROCHLORIDE
18741
A
IV
9/9/2005
LUPIN LTD
MILNACIPRAN HYDROCHLORIDE
18730
A
IV
9/6/2005
MITSUI CHEMICALS INC
MILLION AND MIPELON RESINS
18748
A
IV
9/2/2005
SAI LIFE SCIENCES LTD
MILRINONE
18749
A
IV
9/2/2005
MILRINONE
18750
A
IV
9/2/2005
HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO LTD APTUIT INC
18751
A
IV
9/2/2005
ALBEMARLE CORP
MILRINONE USP
18752
A
IV
9/2/2005
CHEMWERTH INC
MILRINONE, NON-STERILE BULK DRUG
18753
A
IV
9/2/2005
HIKMA PHARMACEUTICALS PLC
MILRINONE, USP
18754
A
IV
9/2/2005
MILPRINT INC
MILSEAL 31100 SERIES
18698
A
IV
8/24/2005
KABI PHARMACIA AB
MICTURO (TERODILINE HYDROCHLORIDE) 12.5MG TABS
18745
A
IV
8/10/2005
MSN PHARMACHEM PRIVATE LTD
MILNACIPRAN HYDROCHLORIDE [ROUTE CODE -MR"]
18574
A
IV
8/5/2005
GANES CHEMICALS INC PENNSVILLE DIV
MFG. PACKAGING AND ANALYSIS OF SODIUM PHENOBARBITAL
18549
A
IV
7/25/2005
MF'G PROCEDURES, & CONTROLS
18526
A
IV
7/20/2005
KNOLL PHARMACEUTICAL CO UNIT BASF K&F CORP CLARIANT MASTERBATCHES NORDEN AB
MEVOPUR-WHITE PP00176011
18519
A
IV
7/15/2005
CLARIANT MASTERBATCHES NORDEN AB
MEVOPUR-TRANS BLUE PP5M176061
18542
A
IV
7/12/2005
LEIRAS OY
MFG FACILITY EQUIPMENT AND PERSONEL FOR SITE IN TURKU FINLAND
18450
A
IV
6/22/2005
SYNCHEM CHEMICALS PVT LTD
METOPROLOL TARTRATE
18486
A
IV
6/22/2005
UNICHEM LABORATORIES LTD
METRONIDAZOLE USP
MILRINONE DRUG SUBSTANCE
Page 20
3Q2015 3Q2015EXCEL DMF#
SUBJECT
18367
STATUS TYP SUBMIT DATE HOLDER E A IV 6/21/2005 SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRL A IV 5/19/2005 QUATRUM
18357
A
IV
5/16/2005
PHARMACIA AND UPJOHN SUB PFIZER INC
METHYLPREDNISOLONE 100MG TABLETS
18358
A
IV
5/16/2005
DIOSYNTH BV
METHYLPREDNISOLONE ACETATE
18359
A
IV
5/16/2005
SOCIETA ITALIANA CORTICOSTEROIDI SPA
METHYLPREDNISOLONE ACETATE
18365
A
IV
5/16/2005
SYMBIOTEC PHARMALAB PRIVATE LTD
METHYLPREDNISOLONE ACETATE USP
18366
A
IV
5/16/2005
ANTIBIOTICOS SPA
METHYLPREDNISOLONE AND METHYLPEDNISOLONE ACETATE
18344
A
IV
5/5/2005
SIEGFRIED USA LLC
METHYLPHENIDATE HYDROCHLORIDE USP
18242
A
IV
3/29/2005
HOUBA INC
METHODS,FACILS & CONTRLS-FOR PRODUCT. OF BULK AL (ACT.LIPIDS)CULVER,IN
18406
A
IV
3/23/2005
BASF PHARMA EVIONNAZ SA
METOLAZONE
18407
A
IV
3/15/2005
SUMIKA FINE CHEMICALS CO LTD
METOLAZONE
18189
A
IV
3/14/2005
SIANG TA PHARMACEUTICAL CO LTD
METHOCARBAMOL
18143
A
IV
3/8/2005
CHATTEM CHEMICALS INC
METHAMPHETAMINE HYDROCHLORIDE USP
18130
A
IV
2/25/2005
PFIZER INC
METHACYCLINE HYDROCHLORIDE
18131
A
IV
2/25/2005
PFIZER INC
METHACYCLINE HYDROCHLORIDE
18110
A
IV
2/16/2005
SMRUTHI ORGANICS LTD
METFORMIN HYDROCHLORIDE USP
18096
A
IV
2/8/2005
IOL CHEMICALS AND PHARMACEUTICALS LTD
METFORMIN HYDROCHLORIDE
18033
A
IV
1/29/2005
VACUMET CORP
METALLIZED POLYESTER FILMS
18025
A
IV
1/27/2005
GEDEON RICHTER LTD
MESTRANOL
18011
A
IV
1/14/2005
ASTA WERKE AKTIENGESELLSCHAFT
MESNA AMPOULES
17994
A
IV
1/3/2005
SUN PHARMACEUTICAL INDUSTRIES LTD
MESALAMINE USP
17995
A
IV
12/30/2004
SUN PHARMACEUTICAL INDUSTRIES LTD
MESALAMINE USP
17882
A
IV
12/2/2004
LABORCHEMIE APOLDA GMBH
MENGLYTATE
17835
A
IV
11/17/2004
CHEMPACIFIC CORP
MELPHALAN DRUG SUBSTANCE
17725
A
IV
10/4/2004
GELMAN INSTRUMENT CO
MEDICAL INSTRUMENTATION--MEMBRANE FILTERS & RELATED EQUIP.
17726
A
IV
10/4/2004
CELANESE PLASTICS AND SPECIALTIES CO
MEDICAL PACKAGING ADHESIVES;1.22188-54 IN THE KENTUCKY FACILITY
17718
A
IV
9/30/2004
HI TECH RUBBER INC
MEDICAL COMPONENTS
17760
A
IV
9/28/2004
SYNTEX USA INC
MEDROXYPROGESTERONE ACETATE,BULK
17761
A
IV
9/28/2004
PHARMACIA AND UPJOHN SUB PFIZER INC
MEDRYSONE
17762
A
IV
9/28/2004
ANTIBIOTICOS SPA
MEDRYSONE USP XIX, NON-MICRONIZED AND MICRONIZED
17763
A
IV
9/28/2004
FLAMEL TECHNOLOGIES SA
MEDUSA® PGLUVE TYPE POLYMER
17642
A
IV
8/20/2004
HEBEI HUARONG PHARMACEUTICAL CO LTD
MECOBALAMIN
17612
A
IV
8/13/2004
SAFC INC
MECHLORETHAMINE HYDROCHLORIDE
17607
A
IV
8/9/2004
ORGAMOL SA
MEBEVERINE HYDROCHLORIDE
17576
A
IV
7/30/2004
STRAINTITE
MD-3C-630, 282558: BAG TYPE CLARIFIER FOR ONE-TIME USE
17577
A
IV
7/30/2004
STRAINTITE
MD-3F-420, 282557: BAG TYPE CLARIFIER FOR ONE-TIME USE
17578
A
IV
7/30/2004
STRAINTITE
MD-3F-45, 282554: BAG TYPE CLARIFIER FOR ONE-TIME USE
17533
A
IV
7/9/2004
SAMET PLAST
MASTER BATCHES
18443
METOPROLOL TARTRATE METHYLPREDNISOLONE BASE
Page 21
3Q2015 3Q2015EXCEL DMF# 17492
STATUS TYP SUBMIT DATE HOLDER E A IV 6/28/2004 TAKASAGO INTL CORP
SUBJECT
17515
A
IV
6/28/2004
EMERSON RESOURCES INC
MARCOAT 125N
17473
A
IV
6/7/2004
ZENECA LTD
17436
A
IV
6/1/2004
PHARMACIA AND UPJOHN
17451
A
IV
5/27/2004
BIOCHEMIC GESELLSCHAFT MBH
17452
A
IV
5/27/2004
ZENECA LTD
17390
A
IV
5/18/2004
SCHERING PLOUGH INC
MANUFACTURING SITE,FACILITIES,PERSONNEL & GENERAL OPERATING PROCEDURES OF THE PARENTERAL MANUFACTURING SITE, FACILITIES, PERSONNLE, AND GENERAL OPERATING PROCEDURES OF NICOTINE CONTAINING PRODUCTS IN HELSINGBORG, SWEDEN. MANUFACTURING SITE, FACILITY, PERSONNEL AND GENERAL OPERATING PROCEDURES IN KUNDL, AUSTRIA MANUFACTURING SITE, FACILITY, PERSONNEL AND GENERAL OPERATING PROCEDURES OF THE GOSERELIN BULK DRUG PLANT IN MACCLESFIELD, CHESHIRE, U.K. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.
17391
A
IV
5/18/2004
TENCO ASSEMBLIES INC
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.
17404
A
IV
5/17/2004
PACKAGE CRAFT INC
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.
17331
A
IV
4/21/2004
EASTMAN CHEMICAL CO
17332
A
IV
4/21/2004
WADDINGTON JAYCARE LTD
17276
A
IV
4/5/2004
PHARMA TECHNOLOGY INDUSTRIES INC
17088
A
IV
3/30/2004
CHISSO CORP
17271
A
IV
3/25/2004
VITA TECH INTERNATIONAL INC
17272
A
IV
3/25/2004
ILKIM AS
17274
A
IV
3/25/2004
CENTRAL GLASS CO LTD
17275
A
IV
3/25/2004
KNOLL AG LUDWIGSHAFEN
17242
A
IV
3/5/2004
HELSINN CHEMICALS SA
17213
A
IV
3/1/2004
LABORATORIES PFIZER LIMITADA
17198
A
IV
2/27/2004
SS ORGANICS LTD
17207
A
IV
2/18/2004
BACHEM FINE CHEMICALS INC
17208
A
IV
2/18/2004
DURA PHARMACEUTICALS INC
17155
A
IV
2/16/2004
ADRIA LABORATORIES INC DIV ERBAMONT INC
MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF HOT MELT ADHESIVES IN LONGVIEW, TEXAS. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF INJECTION MOULDED PLASTIC PACKAGING MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN UNION, MISSOURI. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MINAMATA, JAPAN. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TUSTIN, CALIFORNIA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TUZLA (ISTAMBUL) TURKEY. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN UBE-CITY, JAPAN. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN UETERSEN, GERMANY. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SWITZERLAND. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SAO PAULO, BRAZIL. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SADASIVAPET MANDIA, INDIA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SAN DIEGO, CALIFORNIA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SAN DIEGO, CALIFORNIA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN PLAIN CITY, OHIO.
MANUFACTURING SITES, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES AT FINE CHEM CO., LTD. IN OGASA-GUN, JAPAN FOR (R)-4-MERCAPTOPYRROLIDIN-2-ONE, OR (R)
Page 22
3Q2015 3Q2015EXCEL DMF# 17132
STATUS TYP SUBMIT DATE HOLDER E A IV 1/29/2004 LYPHOMED INC
17127
A
IV
1/28/2004
RP SCHERER CORP
17095
A
IV
1/12/2004
WHITEWORTH TOWNE PAULSEN INC
17077
A
IV
1/5/2004
17044
A
IV
12/22/2003
CRISPEN LABORATORIES AND ASCOT INJECTABLES CHELSEA LABORATORIES INC
17079
A
IV
12/17/2003
17080
A
IV
12/17/2003
KEY PHARMACEUTICALS INC SUB SCHERING PLOUGH CORP GUIDELINES ANALYTICAL LABORATORIES INC
17081
A
IV
12/17/2003
HEALTH CARE INDUSTRY INC
17082
A
IV
12/17/2003
DOW CHEMICAL CO
17087
A
IV
12/3/2003
BALL UNIMARK PLASTICS DIV BALL CORP
17071
A
IV
12/2/2003
ORION CORP LTD
16964
A
IV
11/18/2003
HOECHST AG
16909
A
IV
10/7/2003
16895
A
IV
10/6/2003
MEDICAL UNIV OF SOUTH CAROLINA HOSP PHARMACY SISA INC
16886
A
IV
9/26/2003
BEECHAM LABORATORIES DIV OF BEECHAM INC
16854
A
IV
9/23/2003
SIPSY CHIMIE FINE SCA
16821
A
IV
9/2/2003
ANTIBIOTICOS
16823
A
IV
9/2/2003
LEO PHARMACEUTICAL PRODUCTS LTD
16720
A
IV
7/24/2003
INALCO SPA
16697
A
IV
7/9/2003
ASAHI CHEMICAL INDUSTRY CO LTD
16694
A
IV
6/30/2003
HALCYON LABS PRIVATE LTD
16695
A
IV
6/30/2003
PURETEK CORP
16662
A
IV
6/25/2003
INJECTRONICS INC
SUBJECT MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ORLANDO, FLORIDA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN ONTARIO, CANADA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MONROVIA, CALIFORNIA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MELROSE PARK, ILL MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN LAKEVIEW, NEW YORK. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MIAMI, FLORIDA ON 176 ST. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MIAMI, FLORIDA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MICHIGAN, INDIANA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MIDLAND, MICHIGAN. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MILROY, PA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MANKKAA PLANT. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN FRANKFURT. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CHARLESTON, SOUTH CAROLINA. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CAMBRIDGE, MASSACHUSETTS. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BRISTOL, TENNESSEE. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN AVRILLE, FRANCE. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES FOR BULK PROCESS DEVELOPMENT IN RODANO, ITALY. MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES FOR EB 1089 EC CAPSULES IN BALLERUP, DENMARK. MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN PISTOIA, ITALY MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURE IN HOKKAIDO, JAPAN. MANUFACTURING SITE, FACILITIES, PERSONEL AND OPERATING PROCEDURES IN AHMEDABAD, INDIA. MANUFACTURING SITE, FACILITIES, PERSONNEL & GENERAL OPERATING PROCEDURES IN SAN FERNANDO,CA. MANUFACTURING SITE FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BURLINGTON, NORTH CAROLINA.
Page 23
3Q2015 3Q2015EXCEL DMF# 16663
STATUS TYP SUBMIT DATE HOLDER E A IV 6/25/2003 KOLMAR LABORATORIES INC
SUBJECT
16599
A
IV
5/13/2003
BIOMEASURE INC
MANUFACTURING FACILITIES LOCATED IN HOPKINTON, MASSACHUSETTS
16595
A
IV
5/8/2003
SPAN CONTRACT PACKAGING INC
MANUFACTURING FACILITIES IN GREENVILLE, SOUTH CAROLINA
16519
A
IV
4/7/2003
PURDUE FREDERICK CO
MANUFACTURE AND CONTROL OPERATIONS
16520
A
IV
4/7/2003
NAPP CHEMICALS INC
MANUFACTURE AND CONTROL OPERATIONS
16527
A
IV
4/4/2003
FISONS LTD
MANUFACTURE OF DEXTRAN 70 POWDER
16528
A
IV
4/4/2003
3M HEALTH CARE LTD
MANUFACTURE OF FLECAINIDE ACETATE
16494
A
IV
3/25/2003
WYETH INC
MANUF FACILITIES FOR VARIOUS PLANTS OF WYETH LABORATORIES, INC.
16495
A
IV
3/25/2003
ALTANA INC
MANUF FACILITIES, PERSONNEL AND MANUF. CONTROLS
16496
A
IV
3/25/2003
CILAG CHEMIE AG
MANUF FACILS AND CONTROLS FOR ISOPROTERENOL HYDROCHLORIDE
16497
A
IV
3/25/2003
AMERICAN CHEWING GUM INC
MANUF FACILS, PERSONNEL AND CONTROL INFORMATION
16498
A
IV
3/25/2003
NASHUA CORP
MANUF OF BP-1
16500
A
IV
3/25/2003
AMF INC
MANUF OF MICROSPOROUS MEMBRANE FLAT STOCK PRODUCTS FOR PHARM USE
16501
A
IV
3/25/2003
DENKA PHARMCEUTICAL CO LTD
MANUF PROCEDS HUMAN CHORIONIC GONADOTROPIN (HCG)
16502
A
IV
3/25/2003
INOLEX CHEMICAL CO
MANUF PROCEDURE FOR HIGH POTENCY LIPASE
16503
A
IV
3/25/2003
ACIC LTD
MANUF PROCEDURES FOR PROCHLORPERAZINE MALEATE
16489
A
IV
3/24/2003
CIS US INC
16523
A
IV
3/7/2003
FRED HUTCHINSON CANCER RESCTR
16395
A
IV
1/23/2003
TOMITA PHARMACEUTICAL CO LTD
MANUAFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN DEANGELO DRIVE. MANUFACTURE AND QUALITY CONTROL OF THE BC8-SA MONOCLONAL ANTIBODY CONJUGATE (BC8-SA) MAGALDRATE
16366
A
IV
1/15/2003
RPC FORMATIC GMBH
M-71 MOUTHPIECE, MATERIAL NO.35155911
16260
A
IV
1/14/2003
BASELL POLIOLEFINE ITALIA SPA
LUPOLEN 1810 D
16376
A
IV
1/2/2003
MACLIN CO
MACLIN COMPOUND VM-1921---POLYVINYL CHLORIDE ACETATE
16284
A
IV
12/2/2002
BASF AKTIENGESELLSCHAFT
LUPOLEN 5041 H
16285
A
IV
12/2/2002
BASELL POLIOLEFINE ITALIA SPA
LUPOLEN 5231 HX
16231
A
IV
11/4/2002
PHF SA
LUBIPROSTONE
16190
A
IV
10/15/2002
AMPACET CORP
LR-86344 ANTISTAT POLYETHYLENE MASTERBATCH
16138
A
IV
9/23/2002
RANBAXY LABORATORIES LTD
LOVASTATION USP
16126
A
IV
9/6/2002
BIOCON LTD
LOVASTATIN USP
16067
A
IV
7/22/2002
CADILA HEALTHCARE LTD
LOSARTAN POTASSIUM
16068
A
IV
7/22/2002
ZHEJIANG TIANYU PHARMACEUTICAL CO LTD
LOSARTAN POTASSIUM
16069
A
IV
7/22/2002
WANBURY LTD
LOSARTAN POTASSIUM
16037
A
IV
7/3/2002
LORAZETYL
15951
A
IV
4/26/2002
SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT SEKISUI MEDICAL CO LTD
15916
A
IV
3/29/2002
PFANSTIEHL LABORATORIES INC
L-LACTIC ACID, SODIUM SALT, 40% SOLUTION (CATALOG #L-104)
15917
A
IV
3/29/2002
CONTINENTALAFA DISPENSING CO
LLD-500 PUMPS
15895
A
IV
3/12/2002
ER SQUIBB AND SONS INC
LISTING OF INDS
MANUFACTURING SITE FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES.
L-METHIONINE
Page 24
3Q2015 3Q2015EXCEL DMF# 15894
STATUS TYP SUBMIT DATE HOLDER SUBJECT E A IV 3/8/2002 NATIONAL INSTITUTES HEALTH CLINICAL CENTER LISTING ----DIV BIOLOGICS NOTICES (IND'S) PHARMACY DEPT PHARMACEUTICAL DEVELOPMENT SECTION
15888
A
IV
3/4/2002
DEGUSSA AG WERK RADEBEUL
L-ISOLEUCINE
15910
A
IV
2/28/2002
RUETGERS NEASE CHEMICAL CO INC
LITHIUM CARBONATE, BULK
15869
A
IV
2/20/2002
HETERO DRUGS LTD
LISINOPRIL
15861
A
IV
2/19/2002
SD FINE CHEM LTD
LIQUID PARAFFIN BP
15851
A
IV
2/6/2002
GILEAD SCIENCES INC
LIPOSOMAL LURTOTECAN FOR INJECTION (OSI-211)
15834
A
IV
1/31/2002
LIPOID GMBH
15801
A
IV
1/11/2002
PHARMAGLOBE LABORATORIES LTD
LIPOID PG 16:0/18:1-NH4 (1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-PHOSPHATIDYL GLYCEROL AMMONIUM SALT) LINOLENIC ACID
15800
A
IV
1/8/2002
PHARMAGLOBE LABORATORIES LTD
LINOLEIC ACID
15909
A
IV
12/21/2001
SUN PHARMACEUTICAL INDUSTRIES LTD
LITHIUM CARBONATE USP
15806
A
IV
12/7/2001
STEPAN CO
LIPAL 9-LA (POLYOXYETHYLENE (9) LAURYL ETHER
15807
A
IV
12/7/2001
GROUPE LIPHA
15808
A
IV
12/7/2001
PFIZER INC
LIPHA LACASSAGNE; MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES AND PERSONNEL LIPITOR (ATORVASTATIN CALCIUM) 10MG, 20MG, 40MG, 80MG ORALTABLETS
15712
A
IV
11/12/2001
HARMAN FINOCHEM LTD
LIDOCAINE HCI USP
15669
A
IV
10/10/2001
ORSAN SOCIETE ANONYME
L-GLUMATIC ACID HCL
15660
A
IV
10/9/2001
AZICO BIOPHORE INDIA PVT LTD
LEVOTHYROXINE SODIUM
15648
A
IV
10/5/2001
GEDEON RICHTER PLC
LEVONORGESTREL, USP
15628
A
IV
9/10/2001
MSN PHARMACHEM PRIVATE LTD
LEVOMILNACIPRAN HYDROCHLORIDE [ROUTE CODE - "LM"]
15586
A
IV
8/13/2001
HOFFMANN LA ROCHE INC
LEVODOPA INJECTABLE
15547
A
IV
7/15/2001
ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD
LEVETIRACETAM USP (PROCESS II)
15502
A
IV
6/20/2001
ASPEN OSS BV
LEUPRORELIN HIGHLY PURIFIED
15490
A
IV
6/18/2001
CHEMI SPA
LEUPROLIDE ACETATE
15489
A
IV
6/15/2001
GENZYME CORP
LEUPROLIDE ACETATE
15483
A
IV
6/12/2001
BCN PEPTIDES SA
LEUPROLIDE (LEUPRORELIN)
15480
A
IV
6/11/2001
ZENECA PHARMACEUTICALS
LEUKOTRIENES
15471
A
IV
6/5/2001
CYANAMID GMBH
LEUCOVORIN CALCIUM
15460
A
IV
5/31/2001
USV LTD
LETROZOLE USP
15474
A
IV
5/29/2001
ALP PHARM BEIJING CO LTD
LEUCOVORIN CALCIUM
15449
A
IV
5/22/2001
DR REDDYS LABORATORIES LTD
LETROZOLE
15424
A
IV
5/8/2001
TEVA PHARMACEUTICAL INDUSTRIES LTD
LEFLUNOMIDE
15426
A
IV
5/8/2001
SANOFI AVENTIS DEUTSCHLAND GMBH
LEFLUNOMIDE (HWA 486)
15383
A
IV
5/7/2001
LAURYLMETHACRYLATE-ACRYLIC ACID COPOLYMER (POLYMER TP-1980)
15401
A
IV
4/26/2001
PLANTEX LTD CHEMICAL AND PHARMACEUTICAL WORKS TAENAKA KOGYO CO LTD
15386
A
IV
4/18/2001
CHROMA CORP
LC22711 25/1 WHITE COLOR CONCENTRATE
15363
A
IV
3/30/2001
YONSUNG FINE CHEMICALS CO LTD
Latanoprost
15320
A
IV
3/2/2001
SYMED LABS LTD
LANTHANUM CARBONATE
L-CYSTEINE MONOHYDROCHLORIDE MONOHYDRATE
Page 25
3Q2015 3Q2015EXCEL DMF# 15315
STATUS TYP SUBMIT DATE HOLDER E A IV 2/27/2001 NOSCH LABS PRIVATE LTD
LANSOPRAZOLE, USP
15247
A
IV
1/12/2001
LAMOTRIGINE
15294
A
IV
1/12/2001
CHEMO IBERICA SA
LANSOPRAZOLE (PROCESS II)
15212
A
IV
12/27/2000
LONZEAL PHARMACEUTICALS CO LTD
LAMIVUDINE
15206
A
IV
12/20/2000
PIERREL SPA
L-AMINO ACIDS
15204
A
IV
12/19/2000
LPS INDUSTRIES INC
LAMINATIONS VF42, VF43, VF45, VF48, VF49, VF15, VF16, VF54 AND VF60
15114
A
IV
10/6/2000
ZAMBON SPA
LACTULOSE
15055
A
IV
9/20/2000
SEQUENT SCIENTIFIC LTD
LABETALOL HYDROCHLORIDE
15036
A
IV
9/14/2000
LUPIN LTD
L-5-METHYL TETRAHYDROFOLATE CALCIUM (AMORPHOUS)
15027
A
IV
9/7/2000
NIPPON KAYAKU CO LTD
L-~-METHYLDOPA
14989
A
IV
8/24/2000
BASF SE
KOLLIWAX(R) S FINE
14993
A
IV
8/8/2000
KAKEN PHARMACEUTICAL CO LTD
KP-103
14975
A
IV
7/31/2000
BASF SE
KOLLIDON VA 64
14939
A
IV
7/12/2000
IRVINE SCIENTIFIC SALES CO
KI NSM-16 (KIRIN)
14937
A
IV
6/20/2000
IRVINE SCIENTIFIC SALES CO
KI NSM-12 (KIRIN)
14891
A
IV
5/16/2000
NOBEL CHEMS SPA
KETOPROFEN
14836
A
IV
4/14/2000
FUJI CHEMICAL INDUSTRY CO LTD
KB-2413,1-(2-ETHOXYETHYL)-2-(4-METHYL-I-HOMOPIPERAZINYL)BENZIMIDAZOLE
14832
A
IV
4/12/2000
KANEKA BELGIUM NV
KANE ACE B-28A
14823
A
IV
4/11/2000
ALFRED BENZON AS
KALINORM CONTROLLED RELEASE TALBETS 750MG.
14808
A
IV
3/27/2000
JOHNSON MATTHEY 1319
14819
A
IV
3/27/2000
JOHNSON MATTHEY INC PHARMACEUTICAL MATERIALS GROUP SHIONO FINESSE LTD
KAD-1229 DRUG SUBSTANCE
14765
A
IV
3/3/2000
GLENMARK PHARMACEUTICALS LTD
ITRACONAZOLE
14721
A
IV
2/22/2000
GRAESSER LABORATORIES LTD
ISOSORBIDE-2-MONONITRATE
14644
A
IV
12/23/1999
IRVINE SCIENTIFIC SALES CO
IS CHO-V IUF - POWDER
14628
A
IV
12/15/1999
EMCURE PHARMACEUTICALS LTD
IRON SUCROSE COMPLEX SOLUTION
14629
A
IV
12/15/1999
CILAG AG
IRON SUCROSE DRUG SUBSTANCE
14620
A
IV
12/8/1999
OCEAN NANOTECH LLC
IRON OXIDE NANOPARTICLES FOR TARGETED DRUG DELIVERY
14656
A
IV
12/7/1999
ISF
ISF 2469 (CADRALAZINE)
14515
A
IV
11/5/1999
MALLINCKRODT INC
IOVERSOL
14491
A
IV
10/10/1999
ZHEJIANG STARRY PHARMACEUTICAL CO LTD
IOHEXOL
14492
A
IV
10/10/1999
HOVIONE FARMACIENCIA SA
IOHEXOL
14443
A
IV
10/8/1999
PPG PACKAGING AND COATINGS
INTERNAL PROTECTIVE LACQUER COATINGS
14414
A
IV
9/24/1999
SYNTEX USA INC
INTERLEUKIN-1 BETA (RECOMBINANT, E. COLI) (IMMUNEX)
14270
A
IV
6/28/1999
INDUSTRIALE CHIMICA SRL
INDAPAMIDE
14272
A
IV
6/15/1999
QUIMICA SINTETICA SA
INDAPAMIDE
14194
A
IV
6/9/1999
IMIPENEM
14052
A
IV
3/18/1999
SAVIOR LIFETEC CORP TAINAN BRANCH INJECTION PLANT INDUSTRIAS QUIMICAS ESTEVE SA
IBUPROFEN
14031
A
IV
3/8/1999
DAI NIPPON PRINTING CO LTD
IB FILM
IOL CHEMICALS AND PHARMACEUTICALS LTD
SUBJECT
Page 26
3Q2015 3Q2015EXCEL DMF#
13931
STATUS TYP SUBMIT DATE HOLDER E A IV 1/15/1999 SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTD A IV 1/4/1999 LONZA RIVERSIDE
HYDROXYAMPHETAMINE HYDROBROMIDE
13832
A
IV
11/19/1998
SIEGFRIED USA LLC
HYDROCODONE BITARTRATE USP
13855
A
IV
11/16/1998
ANTIBIOTICOS SPA
HYDROCORTISONE 21-HYDROGEN, SUCCINATE, BULK, NON-STERILE
13824
A
IV
11/9/1998
CADILA HEALTHCARE LTD
HYDROCHLOTHIAZIDE USP
13834
A
IV
11/9/1998
CHATTEM CHEMICALS INC
HYDROCODONE BITARTRATE USP
13278
A
IV
10/5/1998
EMS CHEMIE NORTH AMERICA INC
GRIVORY HB 7103 NATURAL
13231
A
IV
9/23/1998
CIPLA LTD
GRANISETRON HYDROCHLORIDE
13163
A
IV
8/31/1998
ASPEN OSS BV
GONADORELIN ACETATE
13149
A
IV
8/25/1998
BACHEM FEINCHEMIKALIEN AG
GLY-HIS-LYS TRIPEPTIDE COPPER CHELATE
13190
A
IV
8/25/1998
LOPAREX LLC
13156
A
IV
8/15/1998
AMPACET CORP
GRADE 27246 D 2.0 CL PET 8400E/000, GRADE 27441 D 3.0 CL PET 8400E/000 AND GRADE 28924 D 3.0 CL BOP 8400E/000 AND GRADE 53907 C 3.0 CL PET 8400E/000 GOLD SMC PP MB 4300218-NE
13102
A
IV
7/29/1998
AUROBINDO PHARMA LTD
GLYBURIDE USP
13091
A
IV
7/23/1998
FARMOS GROUP LTD MEDIPOLAR
GLYBURIDE
13065
A
IV
7/15/1998
HENKEL CORP
GLUCOPON 625 UP
13063
A
IV
7/7/1998
BACHEM INC
GLUCAGON-LIKE PEPTIDE (7-37)
13067
A
IV
7/7/1998
WANBURY LTD
GLUCOSAMINE HYDROCHLORIDE
13000
A
IV
5/19/1998
COMPANHIA INDUSTRIAL DE VIDROS CIV
GLASS VIALS
12945
A
IV
4/6/1998
CARA PARTNERS WALLINGSTOWN LTD
GINKGO BILOBA EXTRACT
12924
A
IV
3/26/1998
MEIJI SEIKA KAISHA LTD
GENTAMICIN SULFATE
12900
A
IV
3/17/1998
GANES CHEMICALS INC PENNSVILLE DIV
GENERAL OPERATING PROCEDS FOR PENNSVILLE, NJ FACILITY
12893
A
IV
3/9/1998
SOLVAY PHARMACEUTICALS
GENERAL INFO-DISCN. INVESTIGATIONAL DRUGS
12859
A
IV
2/15/1998
DINAMITE DIPHARMA SPA
GEMFIBROZIL
12966
A
IV
2/3/1998
GERRESHEIMER BOLESLAWIEC S A
12967
A
IV
2/3/1998
DAIWA SPECIAL GLASS CO LTD
GLASS AMPOULES, VIALS, AND SAMPLES MADE FROM GLASS TUBES FOR VARIOUS PRODUCTS OF HEALTH CARE SECTIONS UP TO CONTENTS OF 30 ML GLASS BOTTLE
12791
A
IV
12/17/1997
SCHOELLER AND HOESCH GMBH
GEFOLUX TDS/HF
12805
A
IV
12/15/1997
CAPSUGEL INC
GELATIN CAPSULES
12787
A
IV
12/9/1997
CIPLA LTD
GEFITINIB
12744
A
IV
11/14/1997
EXCELLA GMBH
GANCICLOVIR
12731
A
IV
10/27/1997
KNOLL AG LUDWIGSHAFEN
GALLOPAMIL HCl
12692
A
IV
10/8/1997
BAYER PHARMA AG
GADOBUTROL
12693
A
IV
10/8/1997
GADOLINIUM DIETHYLENETRIAMINEPENTAACETIC ACID, N. CHICAGO, IL
12640
A
IV
9/3/1997
ABBOTT LABORATORIES CHEMICAL AND AGRICULTURAL PRODUCTS DIV TRIFARMA SPA
12627
A
IV
8/21/1997
RHONE-POULENC
FUMARATE (30,356 R.P.)
12549
A
IV
6/7/1997
MYLAN LABORATORIES LTD
FOSAMPRENAVIR CALCIUM
12524
A
IV
6/2/1997
LUSOCHIMICA SPA
FORMOTEROL FUMARATE DIHYDRATE
12514
A
IV
4/25/1997
PPC INDUSTRIES INC
FORM-FILL-SEAL WEB MATERIAL
13941
SUBJECT HYDROXYCHLOROQUINE SULFATE (USP)
FUROSEMIDE
Page 27
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STATUS TYP SUBMIT DATE HOLDER E A IV 2/11/1997 LINSON LTD
SUBJECT
12329
A
IV
1/16/1997
SIMS SRL
FLUOXETINE HCL
12322
A
IV
1/7/1997
ANDARD MOUNT INTERNATIONAL LTD
FLUOROURACIL
12299
A
IV
12/20/1996
DELMAR CHEMICALS INC
FLUORESCEIN
12243
A
IV
12/6/1996
SCINOPHARM TAIWAN LTD
FLUMAZENIL
12233
A
IV
11/22/1996
ZHEJIANG HISUN PHARMACEUTICAL CO LTD
FLUDARABINE PHOSPHATE, NON-STERILE BULK DRUG
12220
A
IV
10/31/1996
HOFFMANN LA ROCHE INC
FLUCYTOSINE CAPSULES AND MATCHING PLACEBO
12176
A
IV
10/16/1996
SGD SA
FLINT GLASS TYPE III CONTAINERS
12150
A
IV
10/4/1996
ECP ENICHEM POLYMERES FRANCE
FLEXIRENE CM30
12148
A
IV
10/1/1996
SURGICOT INC
FLEXIBLE PACKAGING PRODUCTS AND COMPONENTS
12102
A
IV
8/21/1996
MAPRIMED SA
FLECAINIDE ACETATE PROCESS III (CODE 50970)
11996
A
IV
6/5/1996
CIPLA LTD
FINASTERIDE USP
11963
A
IV
5/9/1996
FARMHISPANIA SA
FH-113 (RAMIPRIL)
11949
A
IV
4/23/1996
JUBILANT GENERICS LTD
FEXOFENADINE HYDROCHLORIDE
11929
A
IV
4/15/1996
SUN PHARMACEUTICAL INDUSTRIES LTD
FESOTERODINE FUMARATE
11868
A
IV
2/27/1996
CAMBRIDGE MAJOR LABS INC
FENOLDOPAM MESYLATE
11819
A
IV
1/17/1996
HEC PHARM USA INC
FELODIPINE NON-STERILE BULK DRUG SUBSTANCE
11797
A
IV
10/27/1995
ROMER AGRICULTURAL ENTERPRISES
FEEDS CONTAINING DES
11678
A
IV
9/13/1995
DUPONT MERCK PHARMACEUTICAL CO
FACILS & CONTROLS FOR THE MANATI, PUERTO RICO LOCATION
11601
A
IV
7/27/1995
NOVOCOL PHARMACEUTICAL CANADA INC
FACILITY AND PROCEDURES IN CAMBRIDGE, ONTARIO
11576
A
IV
7/6/1995
ICI LTD
FACILITY AND OPERATING PROCEDURES IN RUNCORN, CHESHIRE, UNITED KINGDOM
11567
A
IV
6/28/1995
VANCHEM INC
FACILITY AND OPERATING PROCEDURES IN LOCKPORT, NEW YORK
11531
A
IV
5/25/1995
NOVOPHARM LTD
FACILITIES, PERSONNEL,OPERATING PROC. AT ONTARIO, CANADA
11495
A
IV
4/28/1995
IMAGENTS INC
FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN HOUSTON, TX
11454
A
IV
4/17/1995
ROYCE LABORATORIES
FACILITIES, PERSONNEL AND CONTROLS IN FLORIDA
11398
A
IV
3/22/1995
SANOCHEMIA PHARMAZEUTIKA AG
11375
A
IV
3/9/1995
GREENWICH PHARMACEUTICALS INC
FACILITIES PERSONEL AND GENERAL OPERATING PROCEDURES IN THE CHEMICAL PRODUCTION UNIT IN NEUFELD/LEITHA AUSTRIA FACILITIES LOCATED IN HORSHAM, PENNSYLVANIA
11364
A
IV
3/2/1995
FILTRON TECHNOLOGY CORP
FACILITIES LOCATED IN CLINTON, MASSACHUSETTS
11247
A
IV
12/12/1994
WYETH AYERST RESEARCH
FACILITIES AND OPERATING PROCEDURES IN QUEBEC, CANADA
11214
A
IV
11/30/1994
SYNPAC CHEMICALS LTD
FACILITIES AND OPERATING PROCEDURES IN CAMBOIS, ENGLAND
11198
A
IV
11/11/1994
DIOSYNTH BV
11165
A
IV
10/26/1994
GLASROCK POREX DIV
FACILITIES AND OPERATING PROCEDURES AT DIOSYNTH FRANCE S.A. IN USINE SAINTCHARLES ERAGNY-SUR-EPTE, FRANCE FACILITIES AND CONTROLS FOR T-17
11133
A
IV
10/7/1994
TRI X CORP
FACILITIES AND CONTROLS
11111
A
IV
9/29/1994
SE MASSENGILL CO
FACILITIES $ CONTROL
11124
A
IV
9/23/1994
HOUBA INC
FACILITIES & GENERAL OPERATING PROCEDURES ON STATE ROAD, CULVER,IN.
11090
A
IV
9/19/1994
MOLDCRAFT DIV ANCHOR HOCKING CORP
FAC. & PROCEDURES FOR INJECTION MOLDING,CLOSURES & CLOSURE COMPONENTS
11051
A
IV
8/1/1994
SHINKO CHEMICAL CO LTD
EYEDROP CONTAINER UE-5
10958
A
IV
6/24/1994
SAFC BIOSCIENCES INC
EX-CELL(TM) 302 SERUM-FREE MEDIUM, W/O L-GLUTAMINE
10925
A
IV
5/25/1994
SAFC BIOSCIENCES INC
EX-CELL 302 MEDIUM (MODIFIED) CAT. #62630
FLUPHENAZINE HYDROCHLORIDE, BULK FORM
(VET)
Page 28
3Q2015 3Q2015EXCEL DMF# 10870
STATUS TYP SUBMIT DATE HOLDER E A IV 4/14/1994 FONA INTERNATIONAL INC
EU 936.115 NATURAL BITTERING FLAVOR
10629
A
IV
12/21/1993
ESTASAN PR
10611
A
IV
12/6/1993
JUBILANT ORGANOSYS LTD
ESOMEPRAZOLE SODIUM
10580
A
IV
11/17/1993
JUBILANT GENERICS LTD
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
10524
A
IV
10/12/1993
LUPIN LTD
ESCITALOPRAM OXALATE
10495
A
IV
9/23/1993
ABBVIE INC
ERYTHROMYCIN STEARATE
10221
A
IV
5/3/1993
ENOXAPARIN SODIUM USP
10138
A
IV
3/5/1993
SHANDONG CHENZHONG BIOPHARMACEUTICAL CO LTD DAH FENG CAPSULE INDUSTRY CO LTD
EMPTY HARD SHELL VEGETABLE CAPSULES (HYDROXYPROPYL METHYL CELLULOSE)
10071
A
IV
2/3/1993
WESTLAKE LONGVIEW CORP
EMAC SPECIALTY COPOLYMERS
10072
A
IV
2/3/1993
EGON MEYER SA
EMAPLAST 812
10099
A
IV
2/1/1993
QUALICAPS CO LTD
EMPTY GELATIN CAPSULES
9932
A
IV
10/28/1992
GUFIC BIOSCIENCES LTD
ECONAZOLE NITRATE USP
9834
A
IV
8/24/1992
HENKEL CORP
DURO-TAK(TM) 87-624A PRESSURE SENSITIVE ADHESIVE
9822
A
IV
8/14/1992
HENKEL CORP
DURO-TAK 87-617A PRESSURE SENSITIVE ADHESIVE
9756
A
IV
6/24/1992
TEVA PHARMACEUTICAL INDUSTRIES LTD
DULOXETINE HCL
9662
A
IV
4/21/1992
RHODES TECHNOLOGIES
DRONABINOL, 10% IN SESAME OIL
9654
A
IV
4/16/1992
NORAC INC
DRONABINOL
9627
A
IV
3/30/1992
EMMELLEN BIOTECH PHARMACEUTICALS LTD
D-PSEUDOEPHEDRINE HYDROCHLORIDE
9605
A
IV
3/23/1992
WOCKHARDT LTD
D-OXYPHEN BASE
9600
A
IV
3/10/1992
ARCHIMICA SPA
DOXYLAMINE SUCCINATE USP
9557
A
IV
2/21/1992
MICROBIOPHARM JAPAN CO LTD
DOXORUBICIN HYDROCHLORIDE
9578
A
IV
2/21/1992
HUASHU PHARMACEUTICAL CORP
DOXYCYCLINE HYCLATE
9420
A
IV
11/22/1991
MEGAFINE PHARMA P LTD
DONEPEZIL HYDROCHLORIDE (FORM-1), (NON-STERILE DRUG SUBSTANCE)
9429
A
IV
11/1/1991
APOTEX PHARMACHEM INDIA PVT LTD
DONEPEZIL HYDROCHLORIDE USP
9339
A
IV
9/10/1991
IROTEC LABORATORIES
DOBUTAMINE HYDROCHLORIDE
9323
A
IV
9/5/1991
CHEMI SPA
DMPC (DIMYRISTOYL-PHOSPHATIDYLCHOLINE)
9362
A
IV
8/27/1991
FUJIAN SOUTH PHARMACEUTICAL CO LTD
DOCETAXEL ANHYDROUS, NON-STERILE, BULK DRUG SUBSTANCE
9201
A
IV
6/17/1991
GANES CHEMICALS INC PENNSVILLE DIV
DIPYRONE
9155
A
IV
6/10/1991
QIDONG DONGYUE PHARMACEUTICAL CO LTD
DIPHENHYDRAMINE HCL USP
9054
A
IV
4/10/1991
TANABE SEIYAKU CO LTD
DILTIAZEM MALATE
9034
A
IV
3/25/1991
MAPRIMED SA
DILTIAZEM HCL
9014
A
IV
3/13/1991
EUTICALS SPA
DIHYDROLYSERGIC ACID (INTERMEDIATE)
9015
A
IV
3/13/1991
GEDEON RICHTER LTD
DIHYDROLYSERGOL
9005
A
IV
3/7/1991
MEDIMPEX NORTHAMERICA INC
DIHYDROERGOTOXIN METHANESULPHONATE
8997
A
IV
3/1/1991
MEDIMPEX NORTHAMERICA INC
DIHYDROCHLOROTHIAZIDE
8907
A
IV
12/27/1990
PCAS
DICYCLOMINE HYDROCHLORIDE
8733
A
IV
9/17/1990
8602
A
IV
6/7/1990
AMRI RENSSELAER INC SUB ALBANY MOLECULAR DEXTROAMPHETAMINE DRUG INTERMEDIATE RESEARCH INC KV PHARMACEUTICAL CO DESTAB(TM) FERROUS FUMARATE 90 S ULTRA
8481
A
IV
3/15/1990
P ROBERTET INC
DS INDUSTRIE APS
SUBJECT
DERMODOR 4775
Page 29
3Q2015 3Q2015EXCEL DMF# 8463
STATUS TYP SUBMIT DATE HOLDER E A IV 3/5/1990 NIPPON KAYAKU CO LTD
SUBJECT DEOXYSPERGUALIN HYDROCHLORIDE
8403
A
IV
1/27/1990
CADILA HEALTHCARE LTD
DEFERIPRONE
8257
A
IV
10/12/1989
DAPTOMYCIN API
7963
A
IV
2/27/1989
ZHEJIANG MEDICINE CO LTD XINCHANG PHARMACEUTICAL FACTORY CADILA HEALTHCARE LTD
CSA SALT OF CLOPIDOGREL
7940
A
IV
2/21/1989
UBE INDUSTRIES LTD
CS-526 DRUG SUBSTANCE
7977
A
IV
2/14/1989
DAIDS NIAID NIH
7818
A
IV
12/9/1988
3M DRUG DELIVERY SYSTEMS
CURRICULA VITAE (CV) FOR ACUTE INFECTION AND EARLY DISEASE RESEARCH PROGRAM (AIEDRP) INVESTIGATORS. COTRAN(TM) 9715
7774
A
IV
11/15/1988
MGJ
CORELEN/TRESYLENE LINERS
7757
A
IV
11/9/1988
NATIONAL INSTITUTES HEALTH CLINICAL CENTER COOPERATIVE STUDY GROUPS OF CLINICAL STUDIES PANEL PHARMACY DEPT PHARMACEUTICAL DEVELOPMENT SECTION
7705
A
IV
9/30/1988
TAISEI KAKO CO LTD
CONTAINERS FOR PULMONARY,NASAL,ORAL, THROAT,SUBLINGUAL OR EAR
7618
A
IV
8/1/1988
VERNAY LABORATORIES INC
COMPOUND VL 1001 M 422
7477
A
IV
5/5/1988
IND SWIFT LABORATORIES LTD
COLESEVELAM HYDROCHLORIDE
7437
A
IV
4/15/1988
FINE CHEMICALS CORP
CODEINE PHOSPHATE
7397
A
IV
3/25/1988
LONZA AG
CN 343 (SAS)
7351
A
IV
2/18/1988
FGC ACQUISITION COMPANY LLC
CLOSURES FOR USE IN PACKAGING OF PHARMACEUTICAL PRODUCTS
7247
A
IV
12/9/1987
YUNG ZIP CHEMICAL INDUSTRY COMPANY LTD
CLONIDINE HYDROCHLORIDE
7170
A
IV
10/2/1987
EASTERN COOPERATIVE ONCOLOGY GROUP
CLINICAL TRIALS BY ECOG IN BROOKLINE, MASSACHUSETTS.
7114
A
IV
8/17/1987
SUZHOU NUMBER 4 PHARMACUTICAL FACTORY
CLINDAMYCIN HYDROCHLORIDE USP
7027
A
IV
6/17/1987
FERMIC SA DE CV
CLARITHROMYCIN
6996
A
IV
5/29/1987
CIPLA LTD
CITALOPRAM HYDROBROMIDE USP
6995
A
IV
5/22/1987
JUBILANT GENERICS LTD
CITALOPRAM HYDROBROMIDE USP
6745
A
IV
12/22/1986
FERMENTA BIOTECH LTD
CHOLECALCIFEROL USP (CRYSTALLINE VITAMIN D3)
6600
A
IV
9/23/1986
LONZA INC
CHLORHEXIDINE GLUCONATE, 20% SOLUTION, BP 73 & CHLORHEXIDINE DIACETATE
6358
A
IV
5/16/1986
ANTIBIOTICOS INC
CEPHALOTHIN SODIUM;SODIUM CHLORIDE
6252
A
IV
4/4/1986
QILU ANTIBIOTICS PHARMACEUTICAL CO LTD
CEFUROXIME SODIUM, STERILE BULK ANTIBIOTIC DRUG SUBSTANCE
6244
A
IV
4/3/1986
WOCKHARDT LTD
CEFUROXIME SODIUM (STERILE)
6074
A
IV
10/18/1985
NECTAR LIFESCIENCES LTD
CEFEPIME FOR INJECTION USP (STERILE BULK) DRUG SUBSTANCE
5894
A
IV
6/13/1985
POLYONE CORP
CC00018103WE
5849
A
IV
5/22/1985
POLYONE CORP
CC00002127WE
5841
A
IV
5/21/1985
WITTENBURG BV
CAWITON MO SERIES FOR MEDICAL & PHARMACEUTICAL USE
5797
A
IV
3/28/1985
CTX LIFE SCIENCES PVT LTD
CARVEDILOL (ROUTE-II)
5751
A
IV
3/21/1985
POLYDRUG LABORATORIES PVT LTD
CARISOPRODOL
5734
A
IV
2/28/1985
BOLAK CO LTD
CARBOXYMETHYLCELLULOSE CALCIUM
5718
A
IV
2/11/1985
LUBRIZOL ADVANCED MATERIALS INC
CARBOPOL 934P NF, 934 NF, 942NF, AND 940NF POLYMER
5253
A
IV
12/28/1983
SIEGFRIED LTD
Buprenorphine Hydrochloride
5182
A
IV
10/31/1983
BURTON PARSONS AND CO INC
BUFILCON A --PLASTIC BUTTON FOR HYDROPHILIC SOFT CONTACT LENSES
5116
A
IV
5/23/1983
EXXONMOBIL CHEMICAL CO
BROMINATED ISOBUTYLENE - ISOPRENE RUBBER
Page 30
3Q2015 3Q2015EXCEL DMF#
SUBJECT
4940
STATUS TYP SUBMIT DATE HOLDER E A IV 3/29/1983 BOREALIS AG
4663
A
IV
9/16/1982
BETAXOLOL HYDROCHLORIDE, USP
4571
A
IV
4464
A
IV
4192
A
4062
A
4001 3940
BOREALIS HE9621-PH
6/10/1982
ABBOTT LABORATORIES CHEMICAL AND AGRICULTURAL PRODUCTS DIV ASYMCHEM LIFE SCIENCE TIANJIN CO LTD
BETADEX SULFOBUTYL ETHER SODIUM
3/5/1982
ITF CHEMICAL LTDA
BENDAMUSTINE HYDROCHLORIDE
IV
6/18/1981
DAITO PHARMACEUTICALS CO LTD
AZELASTINE HYDROCHLORIDE
IV
1/13/1981
HEC PHARM CO LTD
ATORVASTATIN CALCIUM NON-STERILE BULK DRUG SUBSTANCE
A
IV
12/1/1980
TIANJIN CENTRAL PHARMACEUTICAL CO LTD
ATENOLOL USP
A
IV
9/18/1980
FINE CHEMICALS CORP
ASTEMIZOLE
3943
A
IV
9/2/1980
JANSSEN PHARMACEUTICA NV
ASTEMIZOLE-R 43512
3860
A
IV
7/9/1980
YONWOO CORP
AS30/50-J/PP JAR
3748
A
IV
3/10/1980
DSM RESEARCH
ARNITEL P PM380
3696
A
IV
1/28/1980
SUN PHARMACEUTICAL INDUSTRIES LTD
ARIPIPRAZOLE
3700
A
IV
1/22/1980
CADILA PHARMACEUTICALS LTD
ARIPIPRAZOLE
3504
A
IV
5/1/1979
SHILPA MEDICARE LTD
ANASTROZOLE
3470
A
IV
3/14/1979
MERCK AND CO INC
AMPROLIUM MEDICATED FEED -(3-NITRO-4-HYDROXYPHENYLARSONIC ACID) (VET)
3479
A
IV
3/9/1979
ARCHIMICA SPA
AMRINONE, USP
3484
A
IV
3/9/1979
ZAMBON GROUP SPA
ANA 756
3426
A
IV
1/17/1979
AMPICILLIN TRIHYDRATE
3367
A
IV
11/8/1978
COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SARL ISP FREETOWN FINE CHEMICALS INC
AMPHETAMINE ASPARTATE
3420
A
IV
10/25/1978
AUROBINDO PHARMA LTD
AMPICILLIN SODIUM USP (STERILE) BULK
3235
A
IV
6/22/1978
CADILA HEALTHCARE LTD
AMLODIPINE BESYLATE USP
3127
A
IV
2/16/1978
SA AJINOMOTO OMNICHEM NV
AMINO ACID MIXTURE BAX-D
3015
A
IV
8/24/1977
ALVEO AG
ALVEOLIT TEE 0500 WHITE
3007
A
IV
8/8/1977
CEBAL VERPACKUNGEN GMBH AND CO KG
ALUMINUM TUBES, CAPS AND AEROSOL CANS
2855
A
IV
2/8/1977
TEVA PHARMACEUTICAL INDUSTRIES LTD
ALPRAZOLAM
2822
A
IV
12/23/1976
BIOPHORE INDIA PHARMACEUTICALS PVT LTD
ALOSETRON HYDROCHLORIDE
2811
A
IV
12/6/1976
SMS PHARMACEUTICALS LTD
ALMOTRIPTAN MALATE
2948
A
IV
10/25/1976
SHAKAI PACKAGING PVT LTD
ALUMINIUM SEALS
2584
A
IV
12/19/1975
INTERNATIONAL SPECIALTY PRODUCTS
ADVANTIA PERFORMANCE
2297
A
IV
6/14/1974
NAKODA CHEMICALS LTD
ACETAZOLAMIDE
2151
A
IV
9/6/1973
DR REDDYS LABORATORIES LTD
ABIRATERONE ACETATE
2006
A
IV
10/23/1972
FONA INTERNATIONAL INC
915.843 STRAWBERRY FLAVOR, NATURAL WONF
1939
A
IV
5/18/1972
FONA INTERNATIONAL INC
894.037 N-C NATURAL PEPPERMINT FLAVOR
1879
A
IV
2/25/1972
FONA INTERNATIONAL INC
862.0085U N-C LEMONADE FLAVOR, NAT WONF
1844
A
IV
12/22/1971
FONA INTERNATIONAL INC
852.263 N-C NAT AND ART GOLDEN PUNCH FLAVOR
1870
A
IV
10/20/1971
FONA INTERNATIONAL INC
857.080 NATURAL GRAPEFRUIT EXTRACT (WONF)
1891
A
IV
7/21/1971
FONA INTERNATIONAL INC
863.002 N-C LEMON-LIME FLAVOR, NAT WONF
1529
A
IV
5/20/1970
CSPC ZHONGNUO PHARMACEUTICAL SHIJIAZHUANG CO LTD
6-AMINO-PENICILLANIC ACID (BY DIRECT METHOD)
Page 31
3Q2015 3Q2015EXCEL DMF#
SUBJECT
1499
STATUS TYP SUBMIT DATE HOLDER E A IV 3/6/1970 DIOSYNTH BV
1242
A
IV
10/2/1968
AMPACET CORP
4600454-N TRANS LIGHT BLUE SMC PP MB
1115
A
IV
12/28/1967
VALSPAR CORP
37 MOBIL PACKAGING COATINGS FORMULATIONS S-9094-001, S-9094-002
78
A
IV
9/8/1966
FONA INTERNATIONAL INC
#936.589 COTTON CANDY FLAVOR, ARTIFICIAL (ALCOHOL FREE)
967
A
IV
12/21/1965
WEST PENN PLASTIC INC
28 TABLET DISPENSER
932
A
IV
12/16/1965
BIRGI SANAYI AS
2-30 ML COLOURLESS INJECTION VIALS MADE OF TUBULAR GLASS
100
A
IV
6/2/1965
(-)-HUPERZINE A
800
A
IV
5/7/1964
NINGBO TRADITIONAL CHINESE PHARMACEUTICAL FACTORY GENZYME PHARMACEUTICALS
1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-PHOSPHOGLYCEROL, AMMONIUM SALT (POPG, NH4)
202
A
IV
3/4/1964
HALYARD HEALTH
[14C]-UREA, USP (PYTEST DRUG SUBSTANCE)
721
A
IV
11/5/1963
AMPACET CORP
1800268-NQ AMBER PE MB
720
A
IV
10/23/1963
OCEAN NUTRITION CANADA LTD
18/12 TG COMPLEX CAPSULES
510
A
IV
1/3/1963
AMPACET CORP
111343 BLUE WHITE PE MB
819
A
IV
10/23/1962
SUVEN LIFE SCIENCES LTD
2-(2-ETHOXY PHENOXY) ETHYL BROMIDE - DRUG INTERMEDIATE
495
A
IV
7/25/1962
AMPACET CORP
110849 WHITE HD POLYETHYLENE MASTERBATCH
449
A
IV
9/18/1961
AMPACET CORP
110017-A WHITE POLYETHYLENE MASTERBATCH
420
A
IV
12/7/1960
COLORTECH INC
10868-12 SLIP/ANTIBLOCK POLYETHYLENE CONCENTRATE
368
A
IV
2/24/1960
AMPACET CORP
100388 AB POLYETHYLENE MASTERBATCH
153
A
IV
9/29/1954
GERRESHEIMER PEACHTREE CITY
(PACKAGING MATERIAL) ACTIVATOR CAP
76
A
IV
3/10/1950
FONA INTERNATIONAL INC
#929.125 WATERMELON FLAVOR, ARTIFICIAL
8
A
IV
1/1/1950
BESPAK DIV CONSORT MEDICAL PLC
BK357 & BK361 PHARMACEUTICAL MEETERING VALVE SHARED INFORMATION
6-ALPHA-METHYLPREDNISOLONE SODIUM SUCCINATE
Page 32
